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 2026-07-15.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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
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.
Documents are hosted by the registry — open the source record to download them.
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
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Carcinoma, Non-Small-Cell Lung→
Hoffmann-La Roche