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NCT04685135 · ClinicalTrials.gov registry record · Phase 3

Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

A Phase 3 study of Metastatic Non Small Cell Lung Cancer and Advanced Non-Small-Cell Lung Cancer, sponsored by Mirati Therapeutics.

Active
Registry status
Phase 3
Development phase
453
Enrollment target
20
Study locations

NCT04685135: Active Phase 3 study of Metastatic Non Small Cell Lung Cancer and Advanced Non-Small-Cell Lung Cancer, sponsored by Mirati Therapeutics.

NCT04685135 is a Phase 3 study of Metastatic Non Small Cell Lung Cancer and Advanced Non-Small-Cell Lung Cancer that is active but no longer recruiting, run by Mirati Therapeutics. The registered enrollment target is 453 participants, above the 368-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04685135, a Phase 3 study of Metastatic Non Small Cell Lung Cancer and Advanced Non-Small-Cell Lung Cancer, is active but no longer recruiting, sponsored by Mirati Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
453 participants
Enrollment target
20
Study locations

Study Summary

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

Primary Outcome

Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum o

Conditions Studied

Metastatic Non Small Cell Lung Cancer Advanced Non-Small-Cell Lung Cancer

Interventions

  • DRUG Docetaxel
  • DRUG MRTX849

Study Locations (20)

California

  • Local Institution - 012-898 - Cerritos
  • City of Hope - Duarte (Main Campus) - Duarte
  • Local Institution - 012-898 D - Glendale
  • Local Institution - 012-910-A - Huntington Beach
  • Local Institution - 012-910-C - Irvine
  • City Of Hope - Long Beach
  • Local Institution - 012-910-F - Long Beach
  • Local Institution - 012-910-D - Newport Beach
  • Local Institution - 012-898 C - Santa Ana
  • Providence Medical Group - Santa Rosa - Santa Rosa
  • Local Institution - 012-910-E - Torrance

Florida

  • Local Institution - 012-562-B - Fleming Island
  • Holy Cross Health Fort Lauderdale - Holy Cross Hospital - Fort Lauderdale
  • 21st Century Oncology of Jacksonville - North Lee Street - Jacksonville
  • Local Institution - 012-562-D - Jacksonville
  • Local Institution - 012-562-E - Jacksonville

Colorado

  • Local Institution - 012-951-B - Denver
  • SCL Health - Saint Joseph Hospital Cancer Center - Lafayette
  • Local Institution - 012-872 - Lone Tree
  • Local Institution - 012-951-A - Wheat Ridge

Trial Details

FieldValue
Enrollment Target 453 participants
Start Date 2021-02-23
Est. Completion 2026-07-02
Phase Phase 3
Mirati Therapeutics

49 total trials

What the registry record for NCT04685135 still lists

NCT04685135 is an interventional study that assigns participants to a tested intervention. The registered 453 participants enrollment target is mid-sized for trials with a published cap, above the 368-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (23% higher).

The record links to 2 conditions, with Metastatic Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Docetaxel is the first listed.

NCT04685135 names 20 study sites across 3 states, led by California, Florida, Colorado.

Frequently Asked Questions

What is clinical trial NCT04685135 about?

NCT04685135 is a clinical study titled "Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation". This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

What is the current status of trial NCT04685135?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 453 participants. The study started on 2021-02-23. Estimated completion is 2026-07-02.

What conditions does trial NCT04685135 study?

This clinical trial studies the following conditions: Metastatic Non Small Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer.

What interventions are being tested in trial NCT04685135?

The interventions under investigation include: Docetaxel (DRUG), MRTX849 (DRUG).

Who is sponsoring clinical trial NCT04685135?

This trial is sponsored by Mirati Therapeutics, which has 49 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04685135 being conducted?

This trial has 20 study locations across California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Non Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04685135's enrollment target sits among peer trials

453 12th of 31 higher than 20 of 31 other Metastatic Non Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Non Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT04685135, the US trial registry maintained by the National Library of Medicine. NCT04685135 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.