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NCT07415031ClinicalTrials.gov

A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies

Solid Tumor Study for Long Term Treatment of Cancer Patients Who Have Participated in BMS Parent Studies Investigating Adagrasib (BMS-986503)

RecruitingTaking participants now, according to the registry record.
Contact this study

In brief

This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC)…

Phase 2170 participants sought100 sites20 countries

Categories

Oncology95%Respiratory5%

Registered in 1 registry

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2026-02-17; recorded start 2026-05-06
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are not randomly assignedAllocation is recorded as non-randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Open label (no blinding)Masking is recorded as none (open label)
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 19 other studies in this databaseCounted from the lead sponsor named in the record (Mirati Therapeutics Inc.)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Open-label

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 100 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 170 participants (target), run at 100 sites, across 20 countries.

How this score is built
  • Enrolment21/40

    170 participants (target)

  • Site count23/25

    100 sites

  • Country count15/15

    20 countries

  • Planned duration7/10

    Planned over about 22 months

  • Sponsor scale4/10

    Mirati Therapeutics Inc. has led 19 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.

Conditions

  • Solid Tumors

Eligibility

SexAll
Ages18 Years – No maximum
Healthy volunteersNo

Eligibility as written in the registry

Inclusion Criteria: * Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit. * Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF. Exclusion Criteria: * Participant is not eligible for study treatment per the parent study eligibility criteria. * Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study. * Participants not receiving clinical benefit from parent study drug as assessed by the investigator. Other protocol defined inclusion/exclusion criteria applies.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study typeInterventional
PhasePhase 2
AllocationNot applicable
Intervention modelPARALLEL
Primary purposeTREATMENT
MaskingNONE (0)
Enrolment170 participants sought

Sponsor and collaborators

  • Mirati Therapeutics Inc. Sponsor

Arms and interventions

  • Arm A1EXPERIMENTAL
  • Arm A2EXPERIMENTAL
  • Arm B1EXPERIMENTAL
  • Arm B2EXPERIMENTAL
  • Arm B3EXPERIMENTAL
  • Arm B4EXPERIMENTAL
  • Arm C1EXPERIMENTAL
  • Arm C2EXPERIMENTAL
  • Arm C3EXPERIMENTAL
  • Arm C4EXPERIMENTAL

Interventions

  • Drug Adagrasib

    Specified dose on specified days

  • Drug Cetuximab

    Specified dose on specified days

  • Drug Docetaxel

    Specified dose on specified days

  • Drug Fluorouracil

    Specified dose on specified days

  • Drug Irinotecan

    Specified dose on specified days

  • Drug Leucovorin

    Specified dose on specified days

  • Drug Oxaliplatin

    Specified dose on specified days

  • Drug Pembrolizumab

    Specified dose on specified days

  • Drug Pemetrexed

    Specified dose on specified days

Outcome measures

  1. Primary outcome

    Number of Participants With Adverse Events (AEs)

    Time frame Up to 90 days from last dose or study discontinuation

  2. Primary outcome

    Number of Participants With AEs Leading to Treatment Discontinuation

    Time frame Up to 90 days from last dose or study discontinuation

  3. Primary outcome

    Number of Participants With Serious Adverse Events (SAEs)

    Time frame Up to 90 days from last dose or study discontinuation

  4. Primary outcome

    Number of Participants With AEs Leading to Death

    Time frame Up to 90 days from last dose or study discontinuation

Dates

Start dateMay 6, 2026 (actual)
Primary completionFebruary 16, 2028 (estimated)
CompletionFebruary 16, 2028 (estimated)
First postedFebruary 17, 2026 (actual)
Last updatedAugust 18, 2026
Results postedNot stated in the registry record
Status last verifiedAugust 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

10 sites are recruiting

Australia

FacilityCityState or regionStatus
Local Institution - 0093St LeonardsNew South WalesNot yet recruiting

Belgium

FacilityCityState or regionStatus
Local Institution - 0033GhentNot yet recruiting

Canada

FacilityCityState or regionStatus
Local Institution - 0072VancouverBritish ColumbiaNot yet recruiting

China

FacilityCityState or regionStatus
Local Institution - 0037BeijingBeijing MunicipalityNot yet recruiting
Local Institution - 0038ChangshaHunanNot yet recruiting
Local Institution - 0040ChengduSichuanNot yet recruiting
Local Institution - 0044HangzhouZhejiangNot yet recruiting
Local Institution - 0039JinanShandongNot yet recruiting
Local Institution - 0047LinyiShandongNot yet recruiting
Local Institution - 0048NanchangJiangxiNot yet recruiting
Local Institution - 0046NanjingJiangsuNot yet recruiting
Local Institution - 0043ShanghaiShanghai MunicipalityNot yet recruiting
Local Institution - 0049ShenyangLiaoningNot yet recruiting
Local Institution - 0041Xi'anNot yet recruiting
Local Institution - 0045XiamenFujianNot yet recruiting
Local Institution - 0042ZhengzhouHenanNot yet recruiting

France

FacilityCityState or regionStatus
Local Institution - 0032AngersMaine-et-LoireNot yet recruiting
Local Institution - 0091BesançonDoubsNot yet recruiting
Local Institution - 0090BronRhôneNot yet recruiting
Local Institution - 0085CréteilNot yet recruiting
Local Institution - 0075GleizéRhôneNot yet recruiting
Local Institution - 0065La TroncheIsèreNot yet recruiting
Local Institution - 0059MarseilleNot yet recruiting
Local Institution - 0086NiceAlpes-MaritimesNot yet recruiting
Local Institution - 0076NiceAlpes-MaritimesNot yet recruiting
Local Institution - 0061ParisÎle-de-France RegionNot yet recruiting
Local Institution - 0103PessacAquitaineNot yet recruiting
Local Institution - 0051PoitiersVienneNot yet recruiting
Local Institution - 0058QuimperNot yet recruiting
Local Institution - 0050Saint-HerblainLoire-AtlantiqueNot yet recruiting
Local Institution - 0063Saint-HerblainLoire-AtlantiqueNot yet recruiting
Local Institution - 0078Saint-MandéNot yet recruiting
Local Institution - 0074StrasbourgAlsaceNot yet recruiting
Local Institution - 0077ToursNot yet recruiting

Germany

FacilityCityState or regionStatus
Local Institution - 0012MünchenNot yet recruiting

Greece

FacilityCityState or regionStatus
Local Institution - 0081AthensAttikíNot yet recruiting
Local Institution - 0022AttikiNot yet recruiting
Local Institution - 0087ThessalonikiNot yet recruiting

Hungary

FacilityCityState or regionStatus
Local Institution - 0089BudapestNot yet recruiting
Local Institution - 0067BudapestNot yet recruiting

Israel

FacilityCityState or regionStatus
Local Institution - 0119HaifaNot yet recruiting
Local Institution - 0055JerusalemJerusalemNot yet recruiting
Local Institution - 0106Tel AvivNot yet recruiting

Italy

FacilityCityState or regionStatus
Local Institution - 0053BolognaNot yet recruiting
Local Institution - 0054FlorenceNot yet recruiting
Local Institution - 0052MeldolaNot yet recruiting
Local Institution - 0107MilanNot yet recruiting
Local Institution - 0021MilanNot yet recruiting
Local Institution - 0020OrbassanoNot yet recruiting
Local Institution - 0079PesaroNot yet recruiting

50 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

  1. August 18, 2026

    Site removed

    1 site removed (100 total)

    101100

  2. July 27, 2026

    Site added

    1 site added (101 total)

    100101

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07415031