A Phase 3 interventional study of Alectnib and Cisplatin in Carcinoma, Non-Small-Cell Lung, sponsored by Hoffmann-La Roche. Active, not recruiting at 114 sites in 27 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
Among 27 studies testing alectinib in Carcinoma, Non-Small-Cell Lung — 7 open to participants now, 14 under way, 4 of them phase 3. alectinib · Carcinoma, Non-Small-Cell Lung.
Among the 27 studies testing alectinib in Carcinoma, Non-Small-Cell Lung, this one is the 6th largest by enrollment, is one of 2 that started in 2018, is one of 7 in phase 3, reaches primary completion later than 0 of the 13 other live ones, and was the 15th registered.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's enrollment of 257 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →7 of the 27 studies testing alectinib in Carcinoma, Non-Small-Cell Lung are open now, in 4 countries. Each count lists the studies.
alectinib: first FDA approval 2015 (ALECENSA), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 1,324 Carcinoma, Non-Small-Cell Lung studies recruiting now, 986 (74%) set no upper age limit and 226 (17%) stop at 75 or younger; 34 take children under 18; 39 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →On this site’s reading of the record, alectinib is the treatment under test here. Read study by study →
27 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2018.
Median enrollment 90 across the 27 interventional studies. Of the 13 that completed or were terminated, 9 (69%) have results posted.
14 of 27 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
139 studies in Carcinoma, Non-Small-Cell Lung by Hoffmann-La Roche: 4 open now, 12 under way, 8 of them phase 3. Of 124 finished, 81 (65%) have results posted.
Among the 139 studies in Carcinoma, Non-Small-Cell Lung by Hoffmann-La Roche, this one is the 44th largest by enrollment of the 108 interventional ones, is one of 5 that started in 2018, is one of 43 in phase 3, reaches primary completion later than 0 of the 11 other live ones, and was the 108th registered.
Hoffmann-La Roche’s Carcinoma, Non-Small-Cell Lung studies by the year they started, since 2004.
6 of the studies testing alectinib in Carcinoma, Non-Small-Cell Lung that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05987956Phase 3Medicine Invention Design, IncPharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT05170204Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Participants With Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) | 2027-01-19 |
| NCT03178552Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) | 2027-06-30 |
| NCT04302025Genentech, Inc.A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC) | 2026-11-30 |
| NCT05713006Instituto Nacional de Cancerologia de MexicoAlectinib Pharmacokinetic in Patients With NSCLC | 2026-12-01 |
Among the 27 studies testing alectinib in Carcinoma, Non-Small-Cell Lung, from their registry updates:
Among Hoffmann-La Roche’s 139 in Carcinoma, Non-Small-Cell Lung:
This randomized, active-controlled, multicenter, open-label, Phase III study is designed to investigate the efficacy and safety of alectinib compared with platinum-based in the adjuvant setting. Participants in the experimental arm will receive alectinib at 600 mg orally twice daily (BID) taken with food for 24 months.
Participants in the control arm will receive one of the protocol specified platinum based chemotherapy regimens for 4 cycles. Following treatment completion, participants will be followed up for their disease until disease recurrence. At the time of disease recurrence, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.
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 diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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 tumour. 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.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Drug: Alectnib
Drug: Cisplatin · Drug: Vinorelbine · Drug: Gemcitabine · Drug: Pemetrexed · Drug: Carboplatin
Participants will receive alectinib 600 mg orally BID until completion of treatment period (24 months) or recurrence of disease , unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Also known as: RO5424802
Participants will receive Cisplatin 75 milligrams per square meter (mg/m\^2) on Day 1 every 21 days IV intravenously (IV) until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."
Participants will receive Vinorelbine 25 mg/m\^2 IV on Days 1 and 8 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
Also known as: Navelbine
Participants will receive Gemcitabine 1250 mg/m\^2 on Days 1 and 8 Q21D IV until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first.
Also known as: Gitrabin
Participants will receive 500 mg/m\^2 Day 1 Q21D until completion of treatment period (4 cycles), recurrence of disease, unacceptable toxicity, withdrawal of consent, or death, whichever occurs first."
Also known as: Alimta®
For participants who experience unacceptable toxicity with cisplatin, carboplatin can be used.
Disease-free Survival (DFS), as Assessed by the Investigator
DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
Time frame: Approximately 58 months
Overall Survival (OS)
Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI. OS, defined as the time from randomization to death from any cause.
Time frame: From the date of randomization until death due to any cause up to approximately 8 years
Percentage of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time frame: Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
AEs Grade 3-5 With a Difference in Incidence Rate of at Least 2% Between Treatment Arms
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
Time frame: Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles)
Plasma Concentration of Alectinib
Time frame: Predose (2 hours) Week 3 - Week 96
Plasma Concentration of Alectinib Metabolite M4
Time frame: Predose (2 hours) Week 3 - Week 96
| Milestone | Alectinib | Platinum-Based Chemotherapy |
|---|---|---|
| Started | 130 | 127 |
| Completed | 0 | 0 |
| Not completed | 130 | 127 |
| Withdrew: Withdrawal by subject | 5 | 9 |
| Withdrew: Protocol deviation | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Death | 2 | 5 |
| Withdrew: Study ongoing | 123 | 111 |
DFS, defined as the time from randomization to the first documented recurrence of disease or new primary NSCLC as determined by the investigator through use of an integrated assessment of radiographic data, biopsy sample results (if clinically feasible), and clinical status or death from any cause, whichever occurs first
| months | Alectinib | Platinum-Based Chemotherapy |
|---|---|---|
| Stage II-IIIA population | NA (NA to NA) | 44.4 (27.8 to NA) |
| ITT population | NA (NA to NA) | 41.3 (28.5 to NA) |
Primary OS analysis at approximately 5 years after FPI and final OS analysis at approximately 8 years after FPI. OS, defined as the time from randomization to death from any cause.
Results for this outcome have not been posted.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
| Percentage of participants | Alectinib | Platinum-Based Chemotherapy |
|---|---|---|
| At least one AE | 98.4 | 93.3 |
| AE with fatal outcome | 0 | 0 |
| Grade 3-5 AE | 29.7 | 30.8 |
| Serious AE (SAE) | 13.3 | 8.3 |
| SAE leading to treatment withdrawal | 0.8 | 3.3 |
| SAE leading to dose modification/interruption | 5.5 | 3.3 |
| Related SAE | 1.6 | 6.7 |
| AE leading to treatment withdrawal | 5.5 | 12.5 |
| AE leading to dose modification/interruption | 43.0 | 22.5 |
| Related AE | 93.8 | 89.2 |
| Related AE leading to treatment withdrawal | 5.5 | 11.7 |
| Related AE leading to dose mod./interruption | 38.3 | 21.7 |
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events.
| Percentage of participants | Alectinib | Platinum-Based Chemotherapy |
|---|---|---|
| Neutrophil count decreased | 0 | 10.0 |
| Blood creatinine phosphokinase increased | 6.3 | 0.8 |
| White blood cell count decreased | 0 | 3.3 |
| Nausea | 0 | 4.2 |
| Appendicitis | 3.1 | 0 |
| Neutropenia | 0 | 8.3 |
| Asthenia | 0 | 2.5 |
| ng/mL | Alectinib |
|---|---|
| Week 3 | 382 ± 276.2 |
| Week 6 | 611 ± 70.6 |
| Week 9 | 593 ± 91.4 |
| Week 12 | 581 ± 94.9 |
| Week 24 | 619 ± 93.2 |
| Week 36 | 639 ± 54.1 |
| Week 48 | 551 ± 90.1 |
| Week 60 | 588 ± 58.9 |
| Week 72 | 527 ± 96.5 |
| Week 84 | 515 ± 91.1 |
| Week 96 | 478 ± 106.4 |
| ng/mL | Alectinib |
|---|---|
| Week 3 | 178 ± 111.7 |
| Week 6 | 214 ± 86.3 |
| Week 9 | 213 ± 78.9 |
| Week 12 | 205 ± 94.7 |
| Week 24 | 237 ± 73.2 |
| Week 36 | 238 ± 50.7 |
| Week 48 | 209 ± 51.7 |
| Week 60 | 217 ± 49.7 |
| Week 72 | 213 ± 62.6 |
| Week 84 | 198 ± 65.4 |
| Week 96 | 191 ± 76.8 |
Collected over Until 28 days after the last dose of alectinib (up to 2 years) or 28 days after end of last cycle of chemotherapy (up to 4 cycles). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alectinib | 2/130 (1.5%) | 17/128 (13.3%) | 124/128 (96.9%) |
| Platinum-Based Chemotherapy | 5/127 (3.9%) | 10/120 (8.3%) | 110/120 (91.7%) |
| Event | Alectinib | Platinum-Based Chemotherapy |
|---|---|---|
| AppendicitisInfections and infestations | 4/128 | 0/120 |
| PneumoniaInfections and infestations | 3/128 | 1/120 |
| NauseaGastrointestinal disorders | 0/128 | 2/120 |
| Neutrophil count decreasedInvestigations | 0/128 | 2/120 |
| Acute myocardial infarctionCardiac disorders | 2/128 | 0/120 |
| Febrile neutropeniaBlood and lymphatic system disorders | 0/128 | 1/120 |
| Abdominal painGastrointestinal disorders | 0/128 | 1/120 |
| ColitisGastrointestinal disorders | 0/128 | 1/120 |
| Epigastric discomfortGastrointestinal disorders | 0/128 | 1/120 |
| Pancreatitis acuteGastrointestinal disorders | 0/128 | 1/120 |
| Event | Alectinib | Platinum-Based Chemotherapy |
|---|---|---|
| NauseaGastrointestinal disorders | 10/128 | 87/120 |
| Blood creatine phosphokinase increasedInvestigations | 55/128 | 1/120 |
| ConstipationGastrointestinal disorders | 54/128 | 30/120 |
| Aspartate aminotransferase increasedInvestigations | 53/128 | 6/120 |
| Alanine aminotransferase increasedInvestigations | 43/128 | 11/120 |
| Blood bilirubin increasedInvestigations | 43/128 | 1/120 |
| Decreased appetiteMetabolism and nutrition disorders | 7/128 | 35/120 |
| COVID-19Infections and infestations | 37/128 | 1/120 |
| MyalgiaMusculoskeletal and connective tissue disorders | 36/128 | 2/120 |
| AnaemiaBlood and lymphatic system disorders | 30/128 | 31/120 |
| Age, Continuous(years) | Alectinib | Platinum-Based Chemotherapy | Total |
|---|---|---|---|
| Mean | 53.4 ± 12.5 | 56.6 ± 11.3 | 54.9 ± 12.0 |
| Sex: Female, Male(Participants) | Alectinib | Platinum-Based Chemotherapy | Total |
|---|---|---|---|
| Female | 75 | 59 | 134 |
| Male | 55 | 68 | 123 |
| Ethnicity (NIH/OMB)(Participants) | Alectinib | Platinum-Based Chemotherapy | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 |
| Not Hispanic or Latino | 127 | 122 | 249 |
| Unknown or Not Reported | 2 | 5 | 7 |
| Race (NIH/OMB)(Participants) | Alectinib | Platinum-Based Chemotherapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 72 | 71 | 143 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 55 | 52 | 107 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 4 | 6 |
Showing the first 100 of 114 sites across 27 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alectinib
Carcinoma, Non-Small-Cell Lung →