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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)

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

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 recherchés100 sites20 pays

Catégories

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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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.

  • Present: Registered before enrolment beganFirst posted 2026-02-17; recorded start 2026-05-06
  • Present: Has a defined primary outcomeA primary outcome measure is listed in the record
  • Present: The primary outcome states a time frameThe primary outcome measure records a time frame
  • Not stated: Participants are not randomly assignedAllocation is recorded as non-randomised
  • Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Not stated: Open label (no blinding)Masking is recorded as none (open label)
  • Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • Not stated: 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.
  • Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Present: Sponsor has 19 other studies in this databaseCounted from the lead sponsor named in the record (Mirati Therapeutics Inc.)
  • Present: 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.

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.

Résumé

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.

Affections

  • Solid Tumors

Éligibilité

Éligibilité
SexeTous
Âges18 YearsAucun maximum
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

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.

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étudeInterventionnelle
PhasePhase 2
RépartitionSans objet
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuNONE (0)
Recrutement170 participants recherchés

Promoteur et collaborateurs

  • Mirati Therapeutics Inc. Promoteur

Groupes et interventions

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

Interventions

  • Médicament Adagrasib

    Specified dose on specified days

  • Médicament Cetuximab

    Specified dose on specified days

  • Médicament Docetaxel

    Specified dose on specified days

  • Médicament Fluorouracil

    Specified dose on specified days

  • Médicament Irinotecan

    Specified dose on specified days

  • Médicament Leucovorin

    Specified dose on specified days

  • Médicament Oxaliplatin

    Specified dose on specified days

  • Médicament Pembrolizumab

    Specified dose on specified days

  • Médicament Pemetrexed

    Specified dose on specified days

Critères de jugement

  1. Critère de jugement principal

    Number of Participants With Adverse Events (AEs)

    Délai Up to 90 days from last dose or study discontinuation

  2. Critère de jugement principal

    Number of Participants With AEs Leading to Treatment Discontinuation

    Délai Up to 90 days from last dose or study discontinuation

  3. Critère de jugement principal

    Number of Participants With Serious Adverse Events (SAEs)

    Délai Up to 90 days from last dose or study discontinuation

  4. Critère de jugement principal

    Number of Participants With AEs Leading to Death

    Délai Up to 90 days from last dose or study discontinuation

Dates

Dates
Date de début6 mai 2026 (réelle)
Achèvement principal16 février 2028 (estimée)
Achèvement16 février 2028 (estimée)
Première publication17 février 2026 (réelle)
Dernière mise à jour18 août 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisaoût 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

10 sites sont en recrutement

Australia

Australia
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0093St LeonardsNew South WalesPas encore en recrutement

Belgium

Belgium
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0033GhentPas encore en recrutement

Canada

Canada
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0072VancouverBritish ColumbiaPas encore en recrutement

China

China
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0037BeijingBeijing MunicipalityPas encore en recrutement
Local Institution - 0038ChangshaHunanPas encore en recrutement
Local Institution - 0040ChengduSichuanPas encore en recrutement
Local Institution - 0044HangzhouZhejiangPas encore en recrutement
Local Institution - 0039JinanShandongPas encore en recrutement
Local Institution - 0047LinyiShandongPas encore en recrutement
Local Institution - 0048NanchangJiangxiPas encore en recrutement
Local Institution - 0046NanjingJiangsuPas encore en recrutement
Local Institution - 0043ShanghaiShanghai MunicipalityPas encore en recrutement
Local Institution - 0049ShenyangLiaoningPas encore en recrutement
Local Institution - 0041Xi'anPas encore en recrutement
Local Institution - 0045XiamenFujianPas encore en recrutement
Local Institution - 0042ZhengzhouHenanPas encore en recrutement

France

France
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0032AngersMaine-et-LoirePas encore en recrutement
Local Institution - 0091BesançonDoubsPas encore en recrutement
Local Institution - 0090BronRhônePas encore en recrutement
Local Institution - 0085CréteilPas encore en recrutement
Local Institution - 0075GleizéRhônePas encore en recrutement
Local Institution - 0065La TroncheIsèrePas encore en recrutement
Local Institution - 0059MarseillePas encore en recrutement
Local Institution - 0086NiceAlpes-MaritimesPas encore en recrutement
Local Institution - 0076NiceAlpes-MaritimesPas encore en recrutement
Local Institution - 0061ParisÎle-de-France RegionPas encore en recrutement
Local Institution - 0103PessacAquitainePas encore en recrutement
Local Institution - 0051PoitiersViennePas encore en recrutement
Local Institution - 0058QuimperPas encore en recrutement
Local Institution - 0050Saint-HerblainLoire-AtlantiquePas encore en recrutement
Local Institution - 0063Saint-HerblainLoire-AtlantiquePas encore en recrutement
Local Institution - 0078Saint-MandéPas encore en recrutement
Local Institution - 0074StrasbourgAlsacePas encore en recrutement
Local Institution - 0077ToursPas encore en recrutement

Germany

Germany
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0012MünchenPas encore en recrutement

Greece

Greece
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0081AthensAttikíPas encore en recrutement
Local Institution - 0022AttikiPas encore en recrutement
Local Institution - 0087ThessalonikiPas encore en recrutement

Hungary

Hungary
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0089BudapestPas encore en recrutement
Local Institution - 0067BudapestPas encore en recrutement

Israel

Israel
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0119HaifaPas encore en recrutement
Local Institution - 0055JerusalemJerusalemPas encore en recrutement
Local Institution - 0106Tel AvivPas encore en recrutement

Italy

Italy
ÉtablissementVilleÉtat ou régionStatut
Local Institution - 0053BolognaPas encore en recrutement
Local Institution - 0054FlorencePas encore en recrutement
Local Institution - 0052MeldolaPas encore en recrutement
Local Institution - 0107MilanPas encore en recrutement
Local Institution - 0021MilanPas encore en recrutement
Local Institution - 0020OrbassanoPas encore en recrutement
Local Institution - 0079PesaroPas encore en recrutement

50 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

  1. 18 août 2026

    Site retiré

    1 site removed (100 total)

    101100

  2. 27 juillet 2026

    Site ajouté

    1 site added (101 total)

    100101