A Phase 3 interventional study of zoldonrasib and Placebo in NSCLC, Non-small Cell Lung Cancer and Non-Small Cell Lung Cancer NSCLC, sponsored by Revolution Medicines, Inc.. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Revolution Medicines, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with pembrolizumab and platinum-based chemotherapy doublet compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet.
This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with pembrolizumab and platinum-based chemotherapy doublet will improve progression-free survival compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet when given to patients with previously untreated, 1L metastatic RAS G12D-mutated, non-squamous non-small cell lung cancer (NSCLC).
Patients will be randomized to one of two arms: zoldonrasib + pembrolizumab + platinum-based chemotherapy doublet (Arm A) or placebo + pembrolizumab + platinum-based chemotherapy doublet (Arm B).
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 430 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 →Revolution Medicines, Inc. is the lead sponsor of 20 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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.
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.
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.
study drug in combination with pembrolizumab and platinum-based chemotherapy doublet
Drug: zoldonrasib · Drug: pembrolizumab · Drug: pemetrexed + cisplatin /carboplatin
placebo in combination with pembrolizumab and platinum-based chemotherapy doublet
Drug: Placebo · Drug: pembrolizumab · Drug: pemetrexed + cisplatin /carboplatin
oral tablets
oral tablets
IV infusion or Subcutaneous injection
Drug pages: Pemetrexed · Cisplatin · Carboplatin
IV infusion of either pemetrexed + cisplatin or pemetrexed + carboplatin
Also known as: Platinum-based chemotherapy doublet
Progression free survival (PFS)
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by blinded independent central review (BICR).
Time frame: Up to approximately 5 years
Overall survival (OS)
OS is defined as the time from randomization until death from any cause.
Time frame: Up to approximately 5 years
Objective response rate (ORR)
Objective response is defined as partial response (PR) or complete response (CR) as assessed per RECIST v1.1 by BICR.
Time frame: Up to approximately 5 years
Duration of response (DOR)
DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first. Response and progression are per RECIST v1.1, as assessed by BICR.
Time frame: Up to approximately 5 years
Incidence of adverse events (AEs)
Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: Up to approximately 5 years
Changes in vital signs
Number of patients with changes in vital signs.
Time frame: Up to approximately 5 years
Changes in clinical laboratory test values
Number of patients with changes in clinical laboratory test values.
Time frame: Up to approximately 5 years
Quality of life as assessed with European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
EORTC QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), 7 single item scales (pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a 2-item global health status/quality of life scale. Change from baseline in EORTC QLQ-C30 physical functioning scale and global health status will be assessed. Higher scores on functional scales reflect better functioning, whereas higher scores on symptom scales reflect higher symptom burden.
Time frame: Up to approximately 5 years
Time to confirmed deterioration in physical function and global health status, as measured by EORTC QLQ-C30
Time to confirmed deterioration in physical functioning subscale and overall global health status scale, as measured by EORTC QLQ-C30. Higher scores on the Higher scores on the EORTC QLQ-C30 functional scales reflect better functioning, whereas higher scores on symptom the scales reflect higher symptom burden. Time to confirmed deterioration in EORTC QLQ-C30 physical functioning subscale and overall health status scale is defined as the time from randomization until the date of the first clinically meaningful deterioration, or death.
Time frame: Up to approximately 5 years
Changes in Non-Small Cell Lung Cancer (NSCLC)-related symptoms, measured by the NSCLC-Symptom Assessment Questionnaire (NSCLC-SAQ)
The NSCLC-SAQ is a participant reported outcome measure with seven items assessing key NSCLC symptoms such as: cough, pain, dyspnea, fatigue, and appetite. Change from baseline in pulmonary symptoms of cough and dyspnea will be evaluated, with higher scores indicating more severe symptoms.
Time frame: Up to approximately 5 years
Time to Confirmed Deterioration of NSCLC-related symptoms, as measured by NSCLC-SAQ
Time to confirmed deterioration in patient-reported pulmonary symptoms of cough and dypsnea, as measured by NSCLC-SAQ. Higher scores for the pulmonary symptoms on the NSCLC-SAQ indicate more severe symptoms. Time to confirmed deterioration in NSCLC-SAQ measures is defined as the time from randomization until the date of the first clinically meaningful deterioration, or death.
Time frame: Up to approximately 5 years
Concentration of zoldonrasib in Arm A
Pre-dose trough and post-dose blood concentrations of zoldonrasib at selected visits.
Time frame: Up to Cycle 5 Day 1 (each cycle is 21 days)
Started Aug 2026 (actual). Primary completion is estimated for Oct 2029, 38 months after the start.
Of 314 industry-sponsored phase 3 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's planned 38 months is close to that.
Counting every sponsor, half of 423 studies reached it within 45 months; a quarter within 30 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Zoldonrasib
Carcinoma, Non-Small-Cell Lung →