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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline up to eos (approximately 5.5 years)

Awards & highlights

Study Summary

This trial compares how well two treatments keep cancer from growing or spreading in people with advanced lung cancer.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline up to eos (approximately 5.5 years)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival (PFS)

Secondary outcome measures

Area Under The Curve (AUC) of Sotorasib

Change in Global Health Status as Measured by QLQ-C30

Change in Physical Function as Measured by QLQ-C30

+22 more

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064

14%

Constipation

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,371 Previous Clinical Trials

1,377,468 Total Patients Enrolled

MDStudy DirectorAmgen

915 Previous Clinical Trials

923,980 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is participation in this study presently being solicited?

"As indicated on clinicaltrials.gov, the trial is currently enrolling participants. The protocol was published and last amended on November 16th 2023."

Answered by AI

How many participants have enrolled in the research project?

"This trial requires 750 qualified patients to participate from across the globe. Those interested can register at The Alfred Hospital in Melbourne, North carolina and Universitaetsspital Basel in Basel, New South Wales."

Answered by AI

Does the age of 20 or above qualify individuals for participation in this study?

"The requirements for inclusion in this trial stipulate that patients must be between 18-100 years old. Furthermore, there are 49 clinical studies open to candidates below the age of majority and 2,119 trials recruiting seniors above 65."

Answered by AI

To whom is enrollment in this research project open?

"This clinical trial is in search of 750 individuals aged 18 to 100 with non-small cell lung cancer. The additional requirements for inclusion are: histologic or cytological proof of advanced Stage IIIB/ IIIC NSCLC with a KRAS p. G12C alteration and the absence of PD-L1 expression validated through both local laboratory tests and central testing, no record of systemic anticancer therapy in metastatic/unremediable settings, and an Eastern Cooperative Oncology Group (ECOG) score ≤ 1."

Answered by AI

Can you provide a tally of all the Canadian sites running this medical trial?

"18 medical centres, including The Alfred Hospital in Melbourne, Universitaetsspital Basel in Basel, and Duke University Medical Center among others are actively recruiting patients for this clinical trial."

Answered by AI

Are there any known risks associated with the concomitant administration of Sotorasib, carboplatin, and pemetrexed?

"Our team has rated the safety of Sotorasib when combined with carboplatin and pemetrexed as a 3, owing to existing clinical data that supports its efficacy and multiple rounds of research affirming its security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

2023. "A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05920356.

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