A Phase 3 interventional study of Canakinumab and Placebo in Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals. Terminated at 283 sites in 41 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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Among 102 studies in Carcinoma, Non-Small-Cell Lung by Novartis — 8 open to participants now, 15 under way, none of them phase 3. Carcinoma, Non-Small-Cell Lung · Novartis.
Among the 102 studies in Carcinoma, Non-Small-Cell Lung by Novartis, this one has the largest enrollment of the 93 interventional ones that give a count, is one of 10 that started in 2018, is one of 16 in phase 3, and was the 60th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →8 of the 102 studies in Carcinoma, Non-Small-Cell Lung by Novartis are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Australia, Japan
Ages 18+
Novartis Pharmaceuticals · Sites in Netherlands
Ages 18–100
Novartis Pharmaceuticals · Sites in Denmark, Japan
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Australia, Canada and 1 more country
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Canada, Denmark and 4 more countries
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
102 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 40 · Phase 3 16 · Phase 4 3
First in 1998; this study’s year is marked. 10 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,382 is above the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 93 across the 93 interventional studies, 109 across the 5 observational. Of the 78 that completed or were terminated, 39 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
6 of the studies in Carcinoma, Non-Small-Cell Lung by Novartis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04699188Novartis PharmaceuticalsStudy of JDQ443 in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation | 2027-01-25 |
| NCT02393625Novartis PharmaceuticalsStudy of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer | 2027-04-09 |
| NCT03891953Novartis PharmaceuticalsStudy of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors. | 2027-06-25 |
| NCT03333343Novartis PharmaceuticalsStudy of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC | 2027-07-12 |
| NCT03040973Novartis PharmaceuticalsStudy to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone | 2027-07-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 102 studies in Carcinoma, Non-Small-Cell Lung by Novartis, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary purpose of the study was to compare the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages II -IIIA according to the 8th edition of the American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) and the subset of IIIB (T>5cm N2 disease) completely resected (R0) non-small cell lung cancer (NSCLC).
This was a phase III, multicenter, randomized, double-blind study to evaluate the efficacy and safety of canakinumab as adjuvant therapy in adult patients with stages AJCC/UICC v.8 II-IIIA and IIIB (T>5 cm N2) completely resected (R0) NSCLC.
Approximately 1500 patients were planned to be randomized 1:1 to canakinumab, 200 mg subcutaneously (s.c.) every 3 weeks or matching placebo s.c. every 3 weeks. Patients were planned to continue their assigned treatment until they completed 18 cycles (cycle= 21 days) or experienced any one of the following: non-small cell lung cancer (NSCLC) disease recurrence as determined by Investigator; unacceptable toxicity that precluded further treatment; treatment discontinuation at the discretion of the Investigator or patient; start of a new antineoplastic therapy; death, or loss to follow-up, whichever occurred first. All patients who discontinued from the study treatment were to be followed up every 12 weeks for survival until the final OS analysis or death, loss to follow-up or withdrawal of consent for survival follow-up.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received 200mg of canakinumab subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Drug: Canakinumab
Participants received canakinumab placebo subcutaneously every 3 weeks for up to 18 cycles (approximately 54 weeks)
Drug: Placebo
200 mg of canakinumab administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Canakinumab solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.
Also known as: ACZ885
Placebo administered subcutaneously on day 1 of every 21-day cycle for 18 cycles. Placebo solution for injection was provided by Novartis as ready-to-use pre-filled syringes to be administered by study personnel.
Disease Free Survival (DFS) by Local Investigator
DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence. The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.
Time frame: Up to approximately 4 years
Overall Survival (OS)
Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.
Time frame: Up to approximately 4.3 years
Overall Survival (OS) in PD-L1 Subgroups
Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier curves, medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 \<1%, PD-L1 ≥1% and \<49%, and PD-L1 ≥50%.
Time frame: Up to approximately 4.3 years
Overall Survival (OS) in CD8 Subgroups
Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.
Time frame: up to approximately 4.3 years
Lung Cancer Specific Survival (LCSS)
LCSS is defined as the time from date of randomization to the date of death due to lung cancer. The LCSS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.
Time frame: Up to approximately 4.3 years
Disease Free Survival (DFS) by Local Investigator in PD-L1 Subgroups
DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence. The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date. DFS analysis was performed by baseline programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 \<1%, PD-L1 ≥1% and \<49%, and PD-L1 ≥50%.
Time frame: Up to approximately 4 years
Disease Free Survival (DFS) by Local Investigator in CD8 Subgroups
DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence. The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date. DFS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.
Time frame: Up to approximately 4 years
Canakinumab Serum Concentrations
Serum concentrations of canakinumab were determinded using an ELISA method.
Time frame: Cycle 1 on day 1 (pre-dose), day 8 and 15; Cycle 2, 4, 6, 9 and 12 on day 1 (pre-dose). Cycle=21 days
Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline
Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had an ADA positive result at baseline
Time frame: Baseline
Canakinumab ADA Incidence
Canakinumab ADA incidence on-treatment was calculated as the percentage of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)
Time frame: From baseline up to 130 days after end of treatment, assessed up to approx. 1.5 years
Time to Definitive 10 Point Deterioration Symptom Scores of Pain,Cough and Dyspnea Per European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ)- Lung Cancer (LC) 13 Questionnaire
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. The time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-LC13 symptom score with no later change below this threshold or death due to any cause, whichever occurred earlier.
Time frame: From baseline up to approximately 4 years
Time to Definitive 10 Point Deterioration of Global Health Status/Quality of Life (QoL), Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms. The time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-C30 score with no later change below this threshold or death due to any cause, whichever occured earlier.
Time frame: From baseline up to approximately 4 years
Time to First 10 Point Deterioration for Symptom Scores of Pain, Cough and Dyspnea Per EORTC QLQ-LC13 Questionnaire
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. The time to first 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.
Time frame: From baseline up to approximately 4 years
Time to First 10 Point Deterioration of Global Health Status/QoL, Shortness of Breath and Pain Per EORTC QLQ-C30 Questionnaire
The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms. The time to first 10 point deterioration of global health status/QoL, shortness of breath and pain scores was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.
Time frame: From baseline up to approximately 4 years
Change From Baseline in the Utility Score of the EuroQoL- 5 Dimension- 5 Level (EQ-5D-5L)
EQ-5D-5L was a standardized questionnaire that measured health-related QoL. EQ-5D-5L consisted of 2 components: a health state profile and a visual analogue scale. The health state profile included five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels ranging from 1 (no problems) to 5 (extreme problems). The EQ-5D-5L health state profile responses were converted into single index utility score, ranging from -1 to 1, where lower scores representing a higher level of dysfunction. Published weights are available enabling the calculation of the utility score. A positive change from baseline indicated improvement. This endpoint was assessed throughout the study, including safety and efficacy follow-up (FU) visits. Safety FU visits: every 4 weeks after end of treatment up to 130 days post-last dose. Efficacy FU visits: at 18, 24, 30, 36 and 48 months post-randomization (if no recurrence observed during treatment or safety FU)
Time frame: Baseline, every 3 weeks for 14 months; end of treatment; every 4 weeks up to 130 days post-treatment; at 18,24,30,36 and 48 months post-randomization (if no recurrence); 7 and 28 days post-disease progression, up to approx. 4 years.
The study was conducted across 290 centers in 41 countries. A total of 1830 subjects were screened of which 1382 participants were randomized to treatment on a 1:1 basis.
| Milestone | Canakinumab | Placebo |
|---|---|---|
| Started | 693 | 689 |
| Treated | 692 | 689 |
| Completed | 414 | 420 |
| Not completed | 279 | 269 |
| Withdrew: Progressive disease | 138 | 148 |
| Withdrew: Study terminated by sponsor | 60 | 44 |
| Withdrew: Adverse event | 34 | 31 |
| Withdrew: Patient decision | 27 | 27 |
| Withdrew: Protocol deviation | 4 | 6 |
| Withdrew: Death | 2 | 7 |
| Withdrew: Technical problems | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Physician decision | 13 | 5 |
DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence. The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date.
| Months | Canakinumab | Placebo |
|---|---|---|
| Disease Free Survival (DFS) by Local Investigator | 35.02 (28.55 to NA) | 29.73 (23.72 to NA) |
Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.
| Months | Canakinumab | Placebo |
|---|---|---|
| Overall Survival (OS) | 51.12 (46.95 to NA) | NA (NA to NA) |
Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier curves, medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 \<1%, PD-L1 ≥1% and \<49%, and PD-L1 ≥50%.
| Months | Canakinumab | Placebo |
|---|---|---|
| PD-L1 <1% | NA (NA to NA) | NA (NA to NA) |
| PD-L1 ≥1% and <49% | 46.95 (22.11 to NA) | NA (NA to NA) |
| PD-L1 ≥50% | 51.12 (NA to NA) | NA (NA to NA) |
Overall Survival (OS) is the time from the date of randomization to the date of death due to any cause. The OS was censored at the latest date the subject was known to be alive. The OS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group. OS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.
| Months | Canakinumab | Placebo |
|---|---|---|
| CD8 < median | 46.95 (32.23 to NA) | NA (NA to NA) |
| CD8 ≥ median | 51.12 (NA to NA) | NA (NA to NA) |
LCSS is defined as the time from date of randomization to the date of death due to lung cancer. The LCSS distribution was estimated using the Kaplan-Meier method, and Kaplan-Meier medians and 95% confidence intervals of the medians were presented for each treatment group.
| Months | Canakinumab | Placebo |
|---|---|---|
| Lung Cancer Specific Survival (LCSS) | 51.12 (44.71 to NA) | NA (NA to NA) |
DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence. The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date. DFS analysis was performed by baseline programmed cell death-ligand 1 (PD-L1) expression status: PD-L1 \<1%, PD-L1 ≥1% and \<49%, and PD-L1 ≥50%.
| Months | Canakinumab | Placebo |
|---|---|---|
| PD-L1 <1% | 30.72 (23.52 to NA) | NA (23.03 to NA) |
| PD-L1 ≥1% and <49% | 30.42 (21.42 to NA) | NA (17.05 to NA) |
| PD-L1 ≥50% | 46.95 (19.45 to NA) | NA (22.31 to NA) |
DFS is the time from the date of randomization to the date of the first documented NSCLC disease recurrence as assessed by local investigator radiologically or death due to any cause. Disease recurrence included diagnoses of new primary lung malignancies. Clinical deterioration was not considered as a recurrence of disease. In case of non-conclusive radiological evidence, a biopsy assessment was performed to confirm NSCLC recurrence. The median DFS was estimated using the Kaplan-Meier method. DFS was censored if no DFS event was observed prior to the analysis cut-off date or subjects who received any subsequent anti-neoplastic therapy for NSCLC. The censoring date was the date of last assessment before the cut-off date or NSCLC related anti-neoplastic therapy date. DFS analysis was performed by CD8 subgroups with the median of baseline CD8 expression as cut-off.
| Months | Canakinumab | Placebo |
|---|---|---|
| CD8 < median | 26.58 (20.67 to NA) | NA (25.03 to NA) |
| CD8 ≥ median | 46.95 (28.81 to NA) | NA (23.89 to NA) |
Serum concentrations of canakinumab were determinded using an ELISA method.
| ug/ml | Canakinumab |
|---|---|
| Cycle 1 Day 1 | 0 ± 0 |
| Cycle 1 Day 8 | 18.1 ± 6.53 |
| Cycle 1 Day 15 | 16.9 ± 5.43 |
| Cycle 2 Day 1 | 15.0 ± 4.91 |
| Cycle 4 Day 1 | 29.7 ± 10.3 |
| Cycle 6 Day 1 | 34.7 ± 13.0 |
| Cycle 9 Day 1 | 37.1 ± 14.5 |
| Cycle 12 Day 1 | 38.6 ± 15.5 |
Canakinumab ADA prevalence at baseline was calculated as the percentage of participants who had an ADA positive result at baseline
| Participants | Canakinumab |
|---|---|
| Canakinumab Anti-drug Antibody (ADA) Prevalence at Baseline | 8 |
Canakinumab ADA incidence on-treatment was calculated as the percentage of participants who were treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that was at least the fold titer change greater than the ADA-positive baseline titer)
| Participants | Canakinumab |
|---|---|
| Canakinumab ADA Incidence | 7 |
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. The time to definitive 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-LC13 symptom score with no later change below this threshold or death due to any cause, whichever occurred earlier.
| Months | Canakinumab | Placebo |
|---|---|---|
| Pain | NA (35.45 to NA) | NA (NA to NA) |
| Cough | NA (35.06 to NA) | NA (34.99 to NA) |
| Dyspnea | 28.88 (23.10 to 34.96) | 34.99 (23.13 to NA) |
The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms. The time to definitive 10 point deterioration of global health status/QoL, shortness of breath and pain was defined as the time from the date of randomization to the date of event, which was defined as at least 10 points relative to baseline worsening of the EORTC QLQ-C30 score with no later change below this threshold or death due to any cause, whichever occured earlier.
| Months | Canakinumab | Placebo |
|---|---|---|
| Global health status/QoL | 34.99 (29.93 to NA) | 35.15 (35.15 to NA) |
| Shortness of breath | NA (NA to NA) | 35.15 (34.99 to NA) |
| Pain | 29.93 (28.29 to 35.22) | 36.44 (34.99 to NA) |
The Lung Cancer module of the EORTC's quality of life questionnaire (EORTC QLQ-LC13) was used in conjunction with the EORTC QLQ-C30 and provided information on an additional 13 items specifically related to lung cancer. The lung cancer module incorporated one multi-item scale to assess dyspnea, and 9 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All of the domain scores ranged from 0 to 100. A high score indicated a high level of symptoms. The time to first 10 point deterioration symptom scores of pain, cough and dyspnea was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.
| Months | Canakinumab | Placebo |
|---|---|---|
| Pain | 35.15 (26.58 to NA) | NA (23.06 to NA) |
| Cough | 15.44 (10.38 to 23.06) | 15.01 (9.69 to NA) |
| Dyspnea | 4.17 (3.42 to 5.55) | 4.86 (3.48 to 6.97) |
The EORTC QLQ-C30 was a questionnaire developed to assess the health-related quality of life of cancer participants. It assessed 15 domains consisting of 5 functional domains (physical, role, emotional, cognitive, social) and 9 symptom domains (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global health status/QoL scale. All domain scores ranged from 0 to 100. A high score for the functional or global health status scales indicated a high level of functioning or QoL; a high score for a symptom scale indicated a high level of symptoms. The time to first 10 point deterioration of global health status/QoL, shortness of breath and pain scores was defined as the time from the date of randomization to the first onset of at least 10 points absolute increase from baseline (worsening) in symptoms scores or death due to any cause, whichever occurred earlier.
| Months | Canakinumab | Placebo |
|---|---|---|
| Global health status/QoL | 9.23 (7.10 to 11.76) | 9.07 (7.62 to 11.76) |
| Shortness of breath | 29.14 (23.03 to NA) | NA (23.13 to NA) |
| Pain | 5.49 (4.21 to 6.90) | 5.62 (4.17 to 7.62) |
EQ-5D-5L was a standardized questionnaire that measured health-related QoL. EQ-5D-5L consisted of 2 components: a health state profile and a visual analogue scale. The health state profile included five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels ranging from 1 (no problems) to 5 (extreme problems). The EQ-5D-5L health state profile responses were converted into single index utility score, ranging from -1 to 1, where lower scores representing a higher level of dysfunction. Published weights are available enabling the calculation of the utility score. A positive change from baseline indicated improvement. This endpoint was assessed throughout the study, including safety and efficacy follow-up (FU) visits. Safety FU visits: every 4 weeks after end of treatment up to 130 days post-last dose. Efficacy FU visits: at 18, 24, 30, 36 and 48 months post-randomization (if no recurrence observed during treatment or safety FU)
| Score on a scale | Canakinumab | Placebo |
|---|---|---|
| Week 3 | 0.0 ± 0.11 | 0.0 ± 0.12 |
| Week 6 | 0.0 ± 0.13 | 0.0 ± 0.12 |
| Week 9 | 0.0 ± 0.13 | 0.0 ± 0.13 |
| Week 12 | 0.0 ± 0.12 | 0.0 ± 0.12 |
| Week 15 | 0.0 ± 0.13 | 0.0 ± 0.12 |
| Week 18 | 0.0 ± 0.13 | 0.0 ± 0.13 |
| Week 21 | 0.0 ± 0.13 | 0.0 ± 0.15 |
| Week 24 | 0.0 ± 0.14 | 0.0 ± 0.14 |
| Week 27 | 0.0 ± 0.13 | 0.0 ± 0.14 |
| Week 30 | 0.0 ± 0.13 | 0.0 ± 0.14 |
| Week 33 | 0.0 ± 0.13 | 0.0 ± 0.14 |
| Week 36 | 0.0 ± 0.14 | 0.0 ± 0.15 |
| Week 39 | 0.0 ± 0.15 | 0.0 ± 0.13 |
| Week 42 | 0.0 ± 0.15 | 0.0 ± 0.14 |
| Week 45 | 0.0 ± 0.14 | 0.0 ± 0.14 |
| Week 48 | 0.0 ± 0.14 | 0.0 ± 0.15 |
| Week 51 | 0.0 ± 0.13 | 0.0 ± 0.14 |
| Week 54 | 0.0 ± 0.18 | 0.1 ± 0.12 |
| Week 57 | 0.0 | -0.1 |
| Week 60 | -0.2 | -0.1 |
| Week 63 | 0.0 | — |
| Week 69 | 0.0 | — |
| Safety FU 1 | 0.0 ± 0.15 | 0.0 ± 0.14 |
| Safety FU 2 | 0.0 ± 0.14 | 0.0 ± 0.14 |
| Safety FU 3 | 0.0 ± 0.14 | 0.0 ± 0.15 |
| Safety FU 4 | 0.0 ± 0.15 | 0.0 ± 0.16 |
| Safety FU 5 | 0.0 ± 0.15 | 0.0 ± 0.14 |
| Efficacy FU 1 | 0.0 ± 0.16 | 0.0 ± 0.14 |
| Efficacy FU 2 | 0.0 ± 0.15 | 0.0 ± 0.16 |
| Efficacy FU 3 | 0.0 ± 0.14 | 0.0 ± 0.15 |
| Efficacy FU 4 | 0.0 ± 0.13 | 0.0 ± 0.15 |
| Efficacy FU 5 | 0.0 ± 0.10 | -0.1 ± 0.17 |
| 7 days post disease progression | -0.1 ± 0.16 | -0.1 ± 0.22 |
| 28 days post disease progression | -0.1 ± 0.18 | -0.1 ± 0.18 |
Pre-treatment deaths were collected from day of participant's informed consent to the day before first dose of study medication. On-treatment deaths were collected from start of treatment to 130 days after last dose. Post-treatment follow-up deaths were collected from day 131 after last dose of study treatment to end of study.
| Participants | Canakinumab | Placebo |
|---|---|---|
| Pre-treatment deaths | 0 | 0 |
| On-treatment deaths | 9 | 17 |
| Post-treatment follow-up deaths | 53 | 51 |
| All deaths | 62 | 68 |
Collected over Pre-treatment: from study consent to the day before first dose, up to 28 days. On-treatment: from first dose of study treatment to 130 days after last dose of study medication, up to approx. 1.5 years. Post-treatment follow-up: from 131 days after last dose of study medication until the end of the study, up to approx. 4.3 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants - Pre-treatment | 0/1,382 (0%) | — | — |
| Canakinumab - On-treatment | 9/692 (1.3%) | 141/692 (20.4%) | 465/692 (67.2%) |
| Canakinumab - Post-treatment Follow-up | 53/671 (7.9%) | — | — |
| Placebo - On-treatment | 17/689 (2.5%) | 146/689 (21.2%) | 455/689 (66%) |
| Placebo - Post-treatment Follow-up | 51/662 (7.7%) | — | — |
| Event | All Participants - Pre-treatment | Canakinumab - On-treatment | Canakinumab - Post-treatment Follow-up | Placebo - On-treatment | Placebo - Post-treatment Follow-up |
|---|---|---|---|---|---|
| COVID-19Infections and infestations | — | 48/692 | — | 48/689 | — |
| PneumoniaInfections and infestations | — | 13/692 | — | 9/689 | — |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | — | 7/692 | — | 2/689 | — |
| Myocardial infarctionCardiac disorders | — | 1/692 | — | 4/689 | — |
| COVID-19 pneumoniaInfections and infestations | — | 1/692 | — | 4/689 | — |
| Cerebrovascular accidentNervous system disorders | — | 4/692 | — | 4/689 | — |
| CholecystitisHepatobiliary disorders | — | 1/692 | — | 3/689 | — |
| C-reactive protein increasedInvestigations | — | 0/692 | — | 3/689 | — |
| Intervertebral disc protrusionMusculoskeletal and connective tissue disorders | — | 0/692 | — | 3/689 | — |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | — | 1/692 | — | 3/689 | — |
| Event | All Participants - Pre-treatment | Canakinumab - On-treatment | Canakinumab - Post-treatment Follow-up | Placebo - On-treatment | Placebo - Post-treatment Follow-up |
|---|---|---|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | — | 89/692 | — | 108/689 | — |
| ArthralgiaMusculoskeletal and connective tissue disorders | — | 74/692 | — | 88/689 | — |
| FatigueGeneral disorders | — | 70/692 | — | 60/689 | — |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | — | 67/692 | — | 50/689 | — |
| Alanine aminotransferase increasedInvestigations | — | 65/692 | — | 49/689 | — |
| Weight increasedInvestigations | — | 63/692 | — | 48/689 | — |
| Back painMusculoskeletal and connective tissue disorders | — | 61/692 | — | 56/689 | — |
| HeadacheNervous system disorders | — | 31/692 | — | 60/689 | — |
| DiarrhoeaGastrointestinal disorders | — | 57/692 | — | 48/689 | — |
| Aspartate aminotransferase increasedInvestigations | — | 53/692 | — | 37/689 | — |
| Age, Continuous(Years) | Canakinumab | Placebo | Total |
|---|---|---|---|
| Mean | 61.5 ± 8.90 | 61.6 ± 9.00 | 61.6 ± 8.95 |
| Sex: Female, Male(Participants) | Canakinumab | Placebo | Total |
|---|---|---|---|
| Female | 263 | 257 | 520 |
| Male | 430 | 432 | 862 |
| Race/Ethnicity, Customized(Participants) | Canakinumab | Placebo | Total |
|---|---|---|---|
| White | 393 | 391 | 784 |
| Asian | 248 | 236 | 484 |
| Black or African American | 3 | 4 | 7 |
| American Indian or Alaska Native | 0 | 5 | 5 |
| Multiple | 0 | 1 | 1 |
| Missing | 49 | 52 | 101 |
Showing the first 100 of 283 sites across 41 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data will be available according to the process described on www.clinicalstudydatarequest.com.
Ran from Mar 2018 to primary completion in Mar 2022, 48 months.
Results were first posted in Jan 2024, 1 year 10 months after primary completion. A results delay was requested in Feb 2023.
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Studies of the drug tested here: Canakinumab
Carcinoma, Non-Small-Cell Lung →