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)
In breve
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 partecipanti ricercati100 centri20 paesi
Categorie
Registrato in 1 registro
- ClinicalTrials.govNCT07415031Apri questa scheda su ClinicalTrials.govSincronizzato mese scorso
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Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.
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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.
Sintesi
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.
Patologie
- Solid Tumors
Idoneità
| Sesso | Tutti |
|---|---|
| Età | 18 Years – Nessun massimo |
| Volontari sani | No |
Idoneità come riportata nel registro
Idoneità in frasi semplici
I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.
Disegno dello studio
| Tipo di studio | Interventistico |
|---|---|
| Fase | Fase 2 |
| Assegnazione | Non applicabile |
| Modello di intervento | PARALLEL |
| Finalità principale | TREATMENT |
| Mascheramento | NONE (0) |
| Arruolamento | 170 partecipanti ricercati |
Sponsor e collaboratori
- Mirati Therapeutics Inc. Sponsor
Bracci e interventi
- Arm A1EXPERIMENTAL
- Arm A2EXPERIMENTAL
- Arm B1EXPERIMENTAL
- Arm B2EXPERIMENTAL
- Arm B3EXPERIMENTAL
- Arm B4EXPERIMENTAL
- Arm C1EXPERIMENTAL
- Arm C2EXPERIMENTAL
- Arm C3EXPERIMENTAL
- Arm C4EXPERIMENTAL
Interventi
- Farmaco Adagrasib
Specified dose on specified days
- Farmaco Cetuximab
Specified dose on specified days
- Farmaco Docetaxel
Specified dose on specified days
- Farmaco Fluorouracil
Specified dose on specified days
- Farmaco Irinotecan
Specified dose on specified days
- Farmaco Leucovorin
Specified dose on specified days
- Farmaco Oxaliplatin
Specified dose on specified days
- Farmaco Pembrolizumab
Specified dose on specified days
- Farmaco Pemetrexed
Specified dose on specified days
Esiti misurati
Esito primario
Number of Participants With Adverse Events (AEs)
Orizzonte temporale Up to 90 days from last dose or study discontinuation
Esito primario
Number of Participants With AEs Leading to Treatment Discontinuation
Orizzonte temporale Up to 90 days from last dose or study discontinuation
Esito primario
Number of Participants With Serious Adverse Events (SAEs)
Orizzonte temporale Up to 90 days from last dose or study discontinuation
Esito primario
Number of Participants With AEs Leading to Death
Orizzonte temporale Up to 90 days from last dose or study discontinuation
Date
| Data di inizio | 6 maggio 2026 (effettiva) |
|---|---|
| Conclusione primaria | 16 febbraio 2028 (stimata) |
| Conclusione | 16 febbraio 2028 (stimata) |
| Prima pubblicazione | 17 febbraio 2026 (effettiva) |
| Ultimo aggiornamento | 18 agosto 2026 |
| Risultati pubblicati | Non indicato nella scheda del registro |
| Stato verificato l'ultima volta | agosto 2026 |
«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.
Centri
10 centri stanno reclutando
Australia
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0093 | St Leonards | New South Wales | Non ancora in reclutamento |
Belgium
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0033 | Ghent | Non ancora in reclutamento |
Canada
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0072 | Vancouver | British Columbia | Non ancora in reclutamento |
China
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0037 | Beijing | Beijing Municipality | Non ancora in reclutamento |
| Local Institution - 0038 | Changsha | Hunan | Non ancora in reclutamento |
| Local Institution - 0040 | Chengdu | Sichuan | Non ancora in reclutamento |
| Local Institution - 0044 | Hangzhou | Zhejiang | Non ancora in reclutamento |
| Local Institution - 0039 | Jinan | Shandong | Non ancora in reclutamento |
| Local Institution - 0047 | Linyi | Shandong | Non ancora in reclutamento |
| Local Institution - 0048 | Nanchang | Jiangxi | Non ancora in reclutamento |
| Local Institution - 0046 | Nanjing | Jiangsu | Non ancora in reclutamento |
| Local Institution - 0043 | Shanghai | Shanghai Municipality | Non ancora in reclutamento |
| Local Institution - 0049 | Shenyang | Liaoning | Non ancora in reclutamento |
| Local Institution - 0041 | Xi'an | Non ancora in reclutamento | |
| Local Institution - 0045 | Xiamen | Fujian | Non ancora in reclutamento |
| Local Institution - 0042 | Zhengzhou | Henan | Non ancora in reclutamento |
France
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0032 | Angers | Maine-et-Loire | Non ancora in reclutamento |
| Local Institution - 0091 | Besançon | Doubs | Non ancora in reclutamento |
| Local Institution - 0090 | Bron | Rhône | Non ancora in reclutamento |
| Local Institution - 0085 | Créteil | Non ancora in reclutamento | |
| Local Institution - 0075 | Gleizé | Rhône | Non ancora in reclutamento |
| Local Institution - 0065 | La Tronche | Isère | Non ancora in reclutamento |
| Local Institution - 0059 | Marseille | Non ancora in reclutamento | |
| Local Institution - 0086 | Nice | Alpes-Maritimes | Non ancora in reclutamento |
| Local Institution - 0076 | Nice | Alpes-Maritimes | Non ancora in reclutamento |
| Local Institution - 0061 | Paris | Île-de-France Region | Non ancora in reclutamento |
| Local Institution - 0103 | Pessac | Aquitaine | Non ancora in reclutamento |
| Local Institution - 0051 | Poitiers | Vienne | Non ancora in reclutamento |
| Local Institution - 0058 | Quimper | Non ancora in reclutamento | |
| Local Institution - 0050 | Saint-Herblain | Loire-Atlantique | Non ancora in reclutamento |
| Local Institution - 0063 | Saint-Herblain | Loire-Atlantique | Non ancora in reclutamento |
| Local Institution - 0078 | Saint-Mandé | Non ancora in reclutamento | |
| Local Institution - 0074 | Strasbourg | Alsace | Non ancora in reclutamento |
| Local Institution - 0077 | Tours | Non ancora in reclutamento |
Germany
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0012 | München | Non ancora in reclutamento |
Greece
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0081 | Athens | Attikí | Non ancora in reclutamento |
| Local Institution - 0022 | Attiki | Non ancora in reclutamento | |
| Local Institution - 0087 | Thessaloniki | Non ancora in reclutamento |
Hungary
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0089 | Budapest | Non ancora in reclutamento | |
| Local Institution - 0067 | Budapest | Non ancora in reclutamento |
Israel
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0119 | Haifa | Non ancora in reclutamento | |
| Local Institution - 0055 | Jerusalem | Jerusalem | Non ancora in reclutamento |
| Local Institution - 0106 | Tel Aviv | Non ancora in reclutamento |
Italy
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Local Institution - 0053 | Bologna | Non ancora in reclutamento | |
| Local Institution - 0054 | Florence | Non ancora in reclutamento | |
| Local Institution - 0052 | Meldola | Non ancora in reclutamento | |
| Local Institution - 0107 | Milan | Non ancora in reclutamento | |
| Local Institution - 0021 | Milan | Non ancora in reclutamento | |
| Local Institution - 0020 | Orbassano | Non ancora in reclutamento | |
| Local Institution - 0079 | Pesaro | Non ancora in reclutamento |
Nella scheda del registro sono indicati altri 50 centri.
Documenti dello studio
In questa scheda del registro non sono collegati documenti.
Modifiche nel tempo
- 18 agosto 2026
Centro rimosso
1 site removed (100 total)
101100
- 27 luglio 2026
Centro aggiunto
1 site added (101 total)
100101