430 Participants NeededMy employer runs this trial

Pembrolizumab + Chemotherapy for Lung Cancer

(RASolve 308 Trial)

Recruiting at 3 trial locations
RM
Overseen ByRevolution Medicines Study Director
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with advanced non-squamous non-small cell lung cancer that has a specific RAS G12D gene mutation and has spread (metastatic). Participants must not have received prior treatment for their metastatic disease.

Inclusion Criteria

My bone marrow, liver, kidneys, blood clotting, and thyroid are working well.
Able to take oral medications
I am fully active or restricted in physically strenuous activity only.
See 5 more

Exclusion Criteria

I am not able or willing to attend all required study visits or procedures.
Additional inclusion and exclusion criteria may apply
I do not have any conditions that affect how I take or absorb medication.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zoldonrasib or placebo in combination with pembrolizumab and platinum-based chemotherapy doublet

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Cisplatin
  • Pembrolizumab
  • Pemetrexed
  • Placebo
  • Zoldonrasib

Trial Overview

The study compares adding an experimental drug called zoldonrasib to standard treatment (pembrolizumab plus pemetrexed and platinum chemotherapy) versus using a placebo with the same standard drugs. Patients are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A: zoldonrasib + pembrolizumab + chemotherapy doubletExperimental Treatment3 Interventions
Group II: Arm B: placebo + pembrolizumab + chemotherapy doubletPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Revolution Medicines, Inc.

Lead Sponsor

Trials
14
Recruited
4,500+