A Phase 1/2 interventional study of Divarasib and Pembrolizumab in Non-Small Cell Lung Cancer, sponsored by Hoffmann-La Roche. Recruiting at 71 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Hoffmann-La Roche · Phase 1/2, Interventional, and Treatment
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's planned enrollment of 320 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be enrolled in different cohorts to receive divarasib (different dose levels will be evaluated) once a day (QD) combined with pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W). During the expansion stage, some participants are planned to be randomized to one divarasib combination dose level; other participants are planned to be randomized to another divarasib combination dose level. Divarasib will be given in combination with pembrolizumab.
Drug: Divarasib · Drug: Pembrolizumab
Participants enrolled in this cohort will receive divarasib (different dose levels will be evaluated) QD combined with pembrolizumab 200 mg IV Q3W plus investigator's choice of platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed.
Drug: Divarasib · Drug: Pembrolizumab · Drug: Carboplatin · Drug: Cisplatin · Drug: Pemetrexed
Participants enrolled in this cohort will receive one dose level of divarasib QD.
Drug: Divarasib
Participants enrolled in this cohort will receive one dose level of divarasib QD.
Drug: Divarasib
Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle.
Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle.
Participants will receive IV carboplatin Q3W for four 21-day cycles.
Participants will receive IV cisplatin Q3W for four 21-day cycles.
Participants will receive IV pemetrexed Q3W.
Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline until 60 days after the final dose of study treatment or until initiation of another anti-cancer therapy, whichever occurs first (up to approximately 5 years)
Objective Response Rate (ORR)
The percentage of participants who experience a complete response or partial response, as determined by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Approximately 5 years
Duration of Response (DOR)
The time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time frame: Approximately 5 years
Progression Free Survival (PFS)
The time from randomization, or date of first treatment for participants enrolled prior to the expansion stage, to the first occurrence of disease progression or death from any cause during the study (whichever occurs first), as determined by the investigator according to RECIST v1.1
Time frame: Approximately 5 years
Number of Participants Reporting Presence, Frequency, Severity, and/or Degree of Interference with Daily Function of Symptomatic Side Effects as Assessed Through the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Time frame: Approximately 5 years
Change from Baseline in Symptomatic Side Effects, as Assessed Through use of the PRO-CTCAE
Time frame: Baseline up to approximately 5 years
Percentage of Participants Reporting "Frequent" or "Almost Constant" Diarrhea During the First Three Cycles of Treatment According to the PRO-CTCAE Criteria
Time frame: Approximately 5 years
Percentage of Participants Reporting "Severe" or "Very Severe" Nausea or Vomiting During the First Three Cycles of Treatment According to the PRO-CTCAE
Time frame: Approximately 5 years
Frequency of Participant's Response of the Degree they are Troubled with Treatment Symptoms, as Assessed Through use of the Single-item European Organisation for Research and Treatment of Cancer (EORTC) Item List 46 (IL46)
Time frame: Approximately 5 years
Plasma or CSF Concentration of Divarasib at Specified Timepoints
Optional CSF samples may be collected at the time of disease progression or at any time during the study for participants who have provided written consent and if collection of CSF sample is deemed clinically feasible. Matched optional plasma samples may be drawn at the same time.
Time frame: Approximately 5 years
Identification of Divarasib Recommended Dose
The recommended dose will be based upon the totality of safety, activity, and PK data.
Time frame: Approximately 5 years
Central Nervous System (CNS) Response
Defined as the percentage of participants who experience a complete response or partial response in the brain, as determined by the investigator according to modified RECIST
Time frame: Approximately 5 years
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 ↗
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