What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), including targeted therapies like KRAS G12C inhibitors (e.g., MRTX849) and chemotherapy agents (e.g., docetaxel), often result in side effects such as gastrointestinal issues (diarrhea, nausea), liver enzyme abnormalities, fatigue, neutropenia, anemia, alopecia, and gastrointestinal disturbances. These side effects vary in severity and frequency but are important considerations in the management of NSCLC.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of Non-Small Cell Lung Cancer (NSCLC). For patients with advanced NSCLC harboring a KRAS G12C mutation, sotorasib is an FDA-approved treatment option. Additionally, other targeted therapies for specific genetic mutations in NSCLC include gefitinib for EGFR mutations, and fam-trastuzumab-deruxtecan for HER2 mutations. These treatments represent a shift towards personalized, genotype-directed therapy in NSCLC.

What other types of research exist?

Promising alternatives to MRTX849 (adagrasib) for NSCLC patients include sotorasib (another KRAS G12C inhibitor), which has shown efficacy in clinical trials. Additionally, therapies targeting other mutations or pathways, such as EGFR inhibitors (e.g., osimertinib), ALK inhibitors (e.g., alectinib), and immunotherapies like pembrolizumab, are also viable options. Emerging treatments in clinical trials, such as novel combination therapies involving KRAS inhibitors and other targeted agents or immunotherapies, may also offer new hope for patients in 2024.

← Back to Search

Small Molecule Drug

Adagrasib vs Docetaxel for Non-Small Cell Lung Cancer (KRYSTAL-12 Trial)

Phase 3

Waitlist Available

Research Sponsored by Mirati Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation

Candidacy to receive treatment with docetaxel

Must not have

Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib)

Active brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 49 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new drug called adagrasib against an existing chemotherapy drug, docetaxel. It focuses on patients with advanced lung cancer who have a specific genetic mutation (KRAS G12C) and have already had treatment. The new drug aims to block this mutation in cancer cells to stop their growth.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called KRAS G12C. Participants must have tried chemotherapy with docetaxel, but their cancer still grew. They should be in decent physical shape (ECOG 0-2). People can't join if they've used other drugs targeting the KRAS G12C mutation, have active brain tumors, or received any other cancer treatments after docetaxel.

What is being tested?

The study compares MRTX849 (adagrasib), an experimental drug, to docetaxel, a standard chemotherapy drug. It's designed to see which one is better at controlling NSCLC in patients who already had treatment and whose tumor carries the KRAS G12C mutation.

What are the potential side effects?

Adagrasib may cause side effects like diarrhea, nausea, liver enzyme changes, fatigue and swelling. Docetaxel can lead to hair loss, low blood cell counts increasing infection risk, mouth sores and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung cancer has a specific KRAS G12C mutation.

Select...

I am eligible to be treated with docetaxel.

Select...

I can take care of myself and am up and about more than half of the day.

Select...

My cancer has worsened after treatment with docetaxel.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with a drug targeting KRAS G12C mutation.

Select...

I have active cancer spread to my brain.

Select...

I haven't taken any cancer treatment after my last docetaxel dose.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 49 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~49 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 49 months 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

Duration of Response (DOR)

Objective Response Rate (ORR)

Overall Survival (OS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MRTX849Experimental Treatment1 Intervention

Group II: DocetaxelActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MRTX849

2021

Completed Phase 1

~10

0 / 7Eligibility criteria met

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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as EGFR inhibitors (osimertinib) and ALK inhibitors (crizotinib), work by blocking specific molecules involved in cancer cell growth and survival. KRAS G12C inhibitors like MRTX849 (adagrasib) specifically target the KRAS G12C mutation, which is a common driver in NSCLC, thereby inhibiting cancer cell proliferation. Immunotherapies, such as PD-1/PD-L1 inhibitors (nivolumab, pembrolizumab), enhance the immune system's ability to recognize and destroy cancer cells. Chemotherapy, using agents like cisplatin and paclitaxel, kills rapidly dividing cells, including cancer cells. Understanding these mechanisms is crucial for NSCLC patients as it allows for personalized treatment plans that target the specific genetic and molecular characteristics of their cancer, potentially improving outcomes and reducing side effects.

Emerging therapeutic agents for lung cancer.The efficacy of combining antiangiogenic agents with chemotherapy for patients with advanced non-small cell lung cancer who failed first-line chemotherapy: a systematic review and meta-analysis.