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Checkpoint Inhibitor

Sotorasib Combo vs Pembrolizumab Combo for Advanced Lung Cancer

Phase 3
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of systemic anticancer therapy in metastatic/non-curable settings
Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
Must not have
Symptomatic (treated or untreated) brain metastases
Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to eos (approximately 5.5 years)
Awards & highlights

Summary

This trial is testing two different drug combinations with chemotherapy to see which helps cancer patients live longer without their disease getting worse. One combination includes sotorasib, which targets cancer mutations, and the other includes pembrolizumab, which helps the immune system fight cancer. Pembrolizumab has been shown to improve overall survival in various cancers when combined with chemotherapy.

Who is the study for?
This trial is for adults with advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that has a specific mutation (KRAS p. G12C) and no PD-L1 expression. They should not have had cancer treatment in the metastatic setting, be relatively fit (ECOG ≤ 1), and able to take oral medication.
What is being tested?
The study compares two treatments: Sotorasib with platinum chemotherapy versus Pembrolizumab with the same chemo, focusing on how long patients live without their cancer getting worse.
What are the potential side effects?
Possible side effects include liver problems, diarrhea, muscle pain from Sotorasib; immune reactions, fatigue, skin issues from Pembrolizumab; plus typical chemo-related nausea, hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had any systemic anticancer therapy for incurable cancer.
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My advanced lung cancer is KRAS G12C mutation positive and PD-L1 negative.
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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases that cause symptoms.
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My lung cancer is mixed type with specific cell features.
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I have been treated with a KRAS G12C inhibitor before.
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I haven't had a heart attack or unstable heart conditions in the last 6 months.
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My tumor has a specific genetic change that can be treated with approved medication.
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I cannot take pills due to a stomach or intestine problem.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to eos (approximately 5.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to eos (approximately 5.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS)
Secondary study objectives
Change in Summary Scores and Visual Analogue Scale (VAS) Scores
Disease Control
Duration of Response
+6 more

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064
14%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Normal Hepatic Function
Moderate Hepatic Impairment
Severe Hepatic Impairment

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sotorasib combined with carboplatin and pemetrexedExperimental Treatment1 Intervention
Sotorasib administered in combination with carboplatin and pemetrexed.
Group II: Pembrolizumab combined with carboplatin and pemetrexedActive Control1 Intervention
Pembrolizumab administered in combination with carboplatin and pemetrexed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotorasib
2021
Completed Phase 1
~370

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Sotorasib is a KRAS G12C inhibitor that targets a specific mutation in the KRAS gene, halting cancer cell growth by inhibiting this mutation. Pembrolizumab is a PD-1 inhibitor that blocks the PD-1 pathway, enhancing the immune system's ability to attack cancer cells. These mechanisms are important for NSCLC patients as they allow for personalized treatment strategies based on the genetic and immune characteristics of their tumors, potentially improving treatment efficacy and patient outcomes.
The impact of smoking status on the progression-free survival of non-small cell lung cancer patients receiving molecularly target therapy or immunotherapy versus chemotherapy: A meta-analysis.Emerging therapeutic agents for lung cancer.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,420 Previous Clinical Trials
1,382,200 Total Patients Enrolled
MDStudy DirectorAmgen
961 Previous Clinical Trials
928,115 Total Patients Enrolled
~472 spots leftby Feb 2026
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