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 resumen
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)…
Fase 2170 participantes buscados100 centros20 países
Categorías
Registrado en 1 registro
- ClinicalTrials.govNCT07415031Abrir este registro en ClinicalTrials.govSincronizado el mes pasado
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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.
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
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
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.
Resumen
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.
Afecciones
- Solid Tumors
Elegibilidad
| Sexo | Todos |
|---|---|
| Edades | 18 Years – Sin máximo |
| Voluntarios sanos | No |
Elegibilidad tal como figura en el registro
Elegibilidad en frases sencillas
Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.
Diseño del estudio
| Tipo de estudio | De intervención |
|---|---|
| Fase | Fase 2 |
| Asignación | No aplicable |
| Modelo de intervención | PARALLEL |
| Propósito principal | TREATMENT |
| Enmascaramiento | NONE (0) |
| Inscripción | 170 participantes buscados |
Patrocinador y colaboradores
- Mirati Therapeutics Inc. Patrocinador
Grupos e intervenciones
- Arm A1EXPERIMENTAL
- Arm A2EXPERIMENTAL
- Arm B1EXPERIMENTAL
- Arm B2EXPERIMENTAL
- Arm B3EXPERIMENTAL
- Arm B4EXPERIMENTAL
- Arm C1EXPERIMENTAL
- Arm C2EXPERIMENTAL
- Arm C3EXPERIMENTAL
- Arm C4EXPERIMENTAL
Intervenciones
- Fármaco Adagrasib
Specified dose on specified days
- Fármaco Cetuximab
Specified dose on specified days
- Fármaco Docetaxel
Specified dose on specified days
- Fármaco Fluorouracil
Specified dose on specified days
- Fármaco Irinotecan
Specified dose on specified days
- Fármaco Leucovorin
Specified dose on specified days
- Fármaco Oxaliplatin
Specified dose on specified days
- Fármaco Pembrolizumab
Specified dose on specified days
- Fármaco Pemetrexed
Specified dose on specified days
Variables de resultado
Variable de resultado principal
Number of Participants With Adverse Events (AEs)
Plazo Up to 90 days from last dose or study discontinuation
Variable de resultado principal
Number of Participants With AEs Leading to Treatment Discontinuation
Plazo Up to 90 days from last dose or study discontinuation
Variable de resultado principal
Number of Participants With Serious Adverse Events (SAEs)
Plazo Up to 90 days from last dose or study discontinuation
Variable de resultado principal
Number of Participants With AEs Leading to Death
Plazo Up to 90 days from last dose or study discontinuation
Fechas
| Fecha de inicio | 6 de mayo de 2026 (real) |
|---|---|
| Finalización principal | 16 de febrero de 2028 (estimada) |
| Finalización | 16 de febrero de 2028 (estimada) |
| Primera publicación | 17 de febrero de 2026 (real) |
| Última actualización | 18 de agosto de 2026 |
| Resultados publicados | No indicado en el registro |
| Estado verificado por última vez | agosto de 2026 |
Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.
Ubicaciones
10 centros están en reclutamiento
Australia
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0093 | St Leonards | New South Wales | Aún no recluta |
Belgium
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0033 | Ghent | Aún no recluta |
Canada
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0072 | Vancouver | British Columbia | Aún no recluta |
China
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0037 | Beijing | Beijing Municipality | Aún no recluta |
| Local Institution - 0038 | Changsha | Hunan | Aún no recluta |
| Local Institution - 0040 | Chengdu | Sichuan | Aún no recluta |
| Local Institution - 0044 | Hangzhou | Zhejiang | Aún no recluta |
| Local Institution - 0039 | Jinan | Shandong | Aún no recluta |
| Local Institution - 0047 | Linyi | Shandong | Aún no recluta |
| Local Institution - 0048 | Nanchang | Jiangxi | Aún no recluta |
| Local Institution - 0046 | Nanjing | Jiangsu | Aún no recluta |
| Local Institution - 0043 | Shanghai | Shanghai Municipality | Aún no recluta |
| Local Institution - 0049 | Shenyang | Liaoning | Aún no recluta |
| Local Institution - 0041 | Xi'an | Aún no recluta | |
| Local Institution - 0045 | Xiamen | Fujian | Aún no recluta |
| Local Institution - 0042 | Zhengzhou | Henan | Aún no recluta |
France
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0032 | Angers | Maine-et-Loire | Aún no recluta |
| Local Institution - 0091 | Besançon | Doubs | Aún no recluta |
| Local Institution - 0090 | Bron | Rhône | Aún no recluta |
| Local Institution - 0085 | Créteil | Aún no recluta | |
| Local Institution - 0075 | Gleizé | Rhône | Aún no recluta |
| Local Institution - 0065 | La Tronche | Isère | Aún no recluta |
| Local Institution - 0059 | Marseille | Aún no recluta | |
| Local Institution - 0086 | Nice | Alpes-Maritimes | Aún no recluta |
| Local Institution - 0076 | Nice | Alpes-Maritimes | Aún no recluta |
| Local Institution - 0061 | Paris | Île-de-France Region | Aún no recluta |
| Local Institution - 0103 | Pessac | Aquitaine | Aún no recluta |
| Local Institution - 0051 | Poitiers | Vienne | Aún no recluta |
| Local Institution - 0058 | Quimper | Aún no recluta | |
| Local Institution - 0050 | Saint-Herblain | Loire-Atlantique | Aún no recluta |
| Local Institution - 0063 | Saint-Herblain | Loire-Atlantique | Aún no recluta |
| Local Institution - 0078 | Saint-Mandé | Aún no recluta | |
| Local Institution - 0074 | Strasbourg | Alsace | Aún no recluta |
| Local Institution - 0077 | Tours | Aún no recluta |
Germany
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0012 | München | Aún no recluta |
Greece
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0081 | Athens | Attikí | Aún no recluta |
| Local Institution - 0022 | Attiki | Aún no recluta | |
| Local Institution - 0087 | Thessaloniki | Aún no recluta |
Hungary
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0089 | Budapest | Aún no recluta | |
| Local Institution - 0067 | Budapest | Aún no recluta |
Israel
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0119 | Haifa | Aún no recluta | |
| Local Institution - 0055 | Jerusalem | Jerusalem | Aún no recluta |
| Local Institution - 0106 | Tel Aviv | Aún no recluta |
Italy
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Local Institution - 0053 | Bologna | Aún no recluta | |
| Local Institution - 0054 | Florence | Aún no recluta | |
| Local Institution - 0052 | Meldola | Aún no recluta | |
| Local Institution - 0107 | Milan | Aún no recluta | |
| Local Institution - 0021 | Milan | Aún no recluta | |
| Local Institution - 0020 | Orbassano | Aún no recluta | |
| Local Institution - 0079 | Pesaro | Aún no recluta |
En el registro figuran 50 centros más.
Documentos del estudio
No hay documentos enlazados en este registro.
Cambios a lo largo del tiempo
- 18 de agosto de 2026
Centro eliminado
1 site removed (100 total)
101100
- 27 de julio de 2026
Centro añadido
1 site added (101 total)
100101