A Phase 2 interventional study of PDR001 and LAG525 in Small Cell Lung Cancer, Gastric Adenocarcinoma and Esophageal Adenocarcinoma, sponsored by Novartis Pharmaceuticals. Completed at 20 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-27.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 2, Interventional, and Treatment
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Among 14 studies in Small Cell Lung Carcinoma by Novartis — 4 open to participants now, 5 under way, none of them phase 3. Small Cell Lung Carcinoma · Novartis.
Among the 14 studies in Small Cell Lung Carcinoma by Novartis, this one is the 8th largest by enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2018, is one of 4 in phase 2, and was the 6th registered.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 365 are open to participants now.
Browse Small Cell Lung Carcinoma studies →4 of the 14 studies in Small Cell Lung Carcinoma by Novartis are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Israel
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Australia, Singapore and 1 more country
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Canada, Japan and 1 more country
Ages 18–100
Novartis Pharmaceuticals · Sites in United States, Australia, Canada and 13 more countries
Ages 18–100
By country, each count listing its studies:
Of the 265 Small Cell Lung Carcinoma studies recruiting now, 175 (66%) set no upper age limit and 66 (25%) stop at 75 or younger; 3 take children under 18; 8 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.
14 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 8 · Phase 2 7 · Phase 3 1
First in 1998; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 76 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Median enrollment 80 across the 13 interventional studies. Of the 8 that completed or were terminated, 2 (25%) 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.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Small Cell Lung Carcinoma by Novartis, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this signal seeking study is to determine whether treatment with PDR001 and LAG525 demonstrates sufficient efficacy in advanced malignancies to warrant further study.
This was a phase II, open-label study to determine the efficacy and safety of treatment with the combination of PDR001+LAG525 across multiple tumor types that are relapsed and/or refractory to available standard of care therapies. There were 7 tumor cohorts assessed: 1) Small cell lung cancer, 2) Gastric/esophageal adenocarcinoma, 3) Castration resistant prostate adenocarcinoma (CRPC), 4) Soft tissue sarcoma, 5) Ovarian adenocarcinoma, 6) Advanced well-differentiated neuroendocrine tumors and 7) Diffuse large B cell lymphoma (DLBCL).
Participants were treated with the combination of PDR001 300 mg with LAG525 400 mg once every 3 weeks (Q3W) via intravenous (i.v.) infusion. Participants received study treatment for a maximum of 2 years, or until disease progression (assessed by investigator per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) or the Revised Response Criteria for Malignant Lymphoma criteria (Cheson et al 2007)), unacceptable toxicity, death or discontinuation from study treatment for any other reason.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients eligible for inclusion in this study had to meet all of the following criteria:
Exclusion Criteria:
Patients eligible for this study must not meet any of the following 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.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PDR001 300 mg and LAG525 400 mg administered via i.v. infusion over 30 minutes once every 3 weeks (Q3W). LAG525 was given first followed by PDR001.
Biological: PDR001 · Biological: LAG525
PDR001 is a high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1.
LAG525 is a high-affinity, ligand-blocking, humanized anti-LAG-3 IgG4 antibody which blocks the binding of the known LAG-3 ligand MHC class II to LAG-3.
Clinical Benefit Rate (CBR) at 24 Weeks of PDR001+LAG525 by Tumor Type in Multiple Solid Tumors and Lymphoma
CBR is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. CBR (CR+PR+SD) is reported overall and by tumor type.
Time frame: 24 weeks
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. ORR (CR+PR) is reported overall (including all tumor types).
Time frame: From start of treatment until end of treatment, assessed up to 113 weeks
Time to Response (TTR)
TTR is defined as the time from the date of first dose to the date of first documented response of Complete Response (CR) or Partial Response (PR). In case of solid tumor if a patient did not achieve a confirmed response they were censored at maximum follow-up for patients who had a PFS event (progressed or died due to any cause), or at last adequate tumor assessment date otherwise. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007).
Time frame: From start of treatment to the first documented response of either complete response or partial response, assessed up to 113 weeks
Duration of Response (DOR)
DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time between the date of first documented response (CR or PR) and the date of first documented progression/relapse or death due to any cause within 150 days of the last study drug dose date. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007).
Time frame: From first documented response (CR or PR) to first documented progression or death, assessed up to 113 weeks
Time to Progression (TTP)
TTP is the time from start of treatment to the date of event defined as the first documented progression or death due to underlying cancer. If a patient not had an event, time to progression was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007).
Time frame: From start of treatment to first documented progression or death due to underlying cancer, assessed up to 113 weeks
Progression-Free Survival (PFS)
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 150 days of the last dose. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007).
Time frame: From start of treatment to first documented progression or death, assessed up to 113 weeks
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs including changes in laboratory parameters, vital signs and ECGs qualifying and reported as AEs.
Time frame: From first dose of study treatment until last dose of study treatment plus 150 days post treatment, assessed up to 135 weeks.
Number of Participants With Dose Interruptions and Permanent Discontinuation of Study Drug
Number of participants with at least one dose interruption of PDR001 and LAG525 and number of participants with permanent dose discontinuation of PDR001 and LAG525.
Time frame: From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks.
Dose Intensity
Dose intensity (mg/day) of PDR001 and LAG525 is calculated as cumulative dose in milligrams divided by duration of exposure in days.
Time frame: From first dose of study treatment until last dose of study treatment, assessed up to 113 weeks.
Participants took part in 20 investigative sites in 1 country (United States).
| Milestone | PDR001+LAG525 |
|---|---|
| Started | 76 |
| Full analysis set (fas) | 75 |
| Completed | 4 |
| Not completed | 72 |
| Withdrew: Adverse event | 5 |
| Withdrew: Death | 1 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Physician decision | 9 |
| Withdrew: Progressive disease | 51 |
| Withdrew: Subject/guardian decision | 5 |
CBR is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) and Stable Disease (SD). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD= Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progression. CBR (CR+PR+SD) is reported overall and by tumor type.
| Participants | PDR001+LAG525 |
|---|---|
| Overall | 25 |
| Small cell lung cancer | 3 |
| Gastric/esophageal adenocarcinoma | 2 |
| Castration resistant prostate adenocarcinoma (CRPC) | 5 |
| Soft tissue sarcoma | 4 |
| Ovarian adenocarcinoma | 2 |
| Advanced well-differentiated neuroendocrine tumors | 6 |
| Diffuse large B cell lymphoma (DLBCL) | 3 |
ORR is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. ORR (CR+PR) is reported overall (including all tumor types).
| Participants | PDR001+LAG525 |
|---|---|
| Overall Response Rate (ORR) | 7 |
TTR is defined as the time from the date of first dose to the date of first documented response of Complete Response (CR) or Partial Response (PR). In case of solid tumor if a patient did not achieve a confirmed response they were censored at maximum follow-up for patients who had a PFS event (progressed or died due to any cause), or at last adequate tumor assessment date otherwise. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007).
| months | PDR001+LAG525 |
|---|---|
| Time to Response (TTR) | NA (NA to NA) |
DOR only applies to subjects for whom best overall response is complete response (CR) or partial response (PR). DOR is defined as the time between the date of first documented response (CR or PR) and the date of first documented progression/relapse or death due to any cause within 150 days of the last study drug dose date. If a patient not had an event, duration was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007).
| months | PDR001+LAG525 |
|---|---|
| Duration of Response (DOR) | NA (5.8 to NA) |
TTP is the time from start of treatment to the date of event defined as the first documented progression or death due to underlying cancer. If a patient not had an event, time to progression was censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007).
| months | PDR001+LAG525 |
|---|---|
| Time to Progression (TTP) | 2.8 (2.7 to 3.8) |
PFS is the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause within 150 days of the last dose. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment. Tumor response was based on local investigator assessment. For participants with solid tumors the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and for participants with lymphoma the assessment criteria was the Revised Response Criteria for Malignant Lymphoma (Cheson et al 2007).
| months | PDR001+LAG525 |
|---|---|
| Progression-Free Survival (PFS) | 2.8 (2.6 to 3.1) |
Number of participants with AEs and SAEs including changes in laboratory parameters, vital signs and ECGs qualifying and reported as AEs.
| Participants | PDR001+LAG525 |
|---|---|
| AEs | 75 |
| SAEs | 32 |
Number of participants with at least one dose interruption of PDR001 and LAG525 and number of participants with permanent dose discontinuation of PDR001 and LAG525.
| Participants | PDR001+LAG525 |
|---|---|
| PDR001 - dose interruption | 30 |
| PDR001 - permanent dose discontinuation | 72 |
| LAG525 - dose interruption | 30 |
| LAG525 - permanent dose discontinuation | 72 |
Dose intensity (mg/day) of PDR001 and LAG525 is calculated as cumulative dose in milligrams divided by duration of exposure in days.
| mg/day | PDR001+LAG525 |
|---|---|
| PDR001 | 14.1 ± 0.88 |
| LAG525 | 18.8 ± 1.20 |
Collected over In the on-treatment period, adverse events (AEs) and serious AEs (including the All-Cause Mortality data table) are presented from first dose of study treatment until last dose of study treatment plus 30 days post treatment. In the extended safety follow-up period, AEs and serious AEs (including the All-Cause Mortality data table) are presented from day 31 to day 150 after last administration of study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PDR001+LAG525 On-treatment Period | 9/76 (11.8%) | 31/76 (40.8%) | 74/76 (97.4%) |
| PDR001+LAG525 Extended Safety Follow-up Period | 18/76 (23.7%) | 4/76 (5.3%) | 12/76 (15.8%) |
| Event | PDR001+LAG525 On-treatment Period | PDR001+LAG525 Extended Safety Follow-up Period |
|---|---|---|
| PneumoniaInfections and infestations | 5/76 | 0/76 |
| AstheniaGeneral disorders | 3/76 | 0/76 |
| Abdominal painGastrointestinal disorders | 2/76 | 0/76 |
| NauseaGastrointestinal disorders | 2/76 | 0/76 |
| VomitingGastrointestinal disorders | 2/76 | 0/76 |
| Back painMusculoskeletal and connective tissue disorders | 2/76 | 0/76 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 2/76 | 0/76 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 2/76 | 0/76 |
| LymphadenopathyBlood and lymphatic system disorders | 1/76 | 0/76 |
| Atrial fibrillationCardiac disorders | 1/76 | 0/76 |
| Event | PDR001+LAG525 On-treatment Period | PDR001+LAG525 Extended Safety Follow-up Period |
|---|---|---|
| FatigueGeneral disorders | 28/76 | 0/76 |
| NauseaGastrointestinal disorders | 26/76 | 1/76 |
| Decreased appetiteMetabolism and nutrition disorders | 22/76 | 0/76 |
| ConstipationGastrointestinal disorders | 20/76 | 0/76 |
| VomitingGastrointestinal disorders | 20/76 | 0/76 |
| DyspnoeaCardiac disorders | 18/76 | 1/76 |
| DiarrhoeaGastrointestinal disorders | 15/76 | 1/76 |
| Abdominal painGastrointestinal disorders | 14/76 | 0/76 |
| AnaemiaBlood and lymphatic system disorders | 13/76 | 2/76 |
| Back painMusculoskeletal and connective tissue disorders | 13/76 | 1/76 |
| Age, Continuous(years) | PDR001+LAG525 |
|---|---|
| Mean | 65.1 ± 10.57 |
| Sex: Female, Male(Participants) | PDR001+LAG525 |
|---|---|
| Female | 31 |
| Male | 45 |
| Race/Ethnicity, Customized(Participants) | PDR001+LAG525 |
|---|---|
| Asian | 1 |
| Black | 1 |
| Caucasian | 67 |
| Unknown | 7 |
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 review 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 availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Ran from Jan 2018 to primary completion in Feb 2019, 12 months.
Results were first posted in Apr 2021, 2 years 1 month after primary completion. A results delay was requested in Mar 2019.
Of 54 industry-sponsored phase 2 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 44. This study's 12 months is below that.
Counting every sponsor, half of 204 studies reached it within 46 months; a quarter within 29 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spartalizumab