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NCT05022394
Sapanisertib and Nivolumab for the Treatment of Stage I-IV Non-small Cell Lung Cancer in Patients Who Have Progressed on Prior PD-1/PD-L1 Inhibitor Therapy, I-OVERCOME Study
Phase 1, PHASE2 trial testing Nivolumab in Lung Non-Small Cell Carcinoma. Withdrawn.
18 February 2021
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 18 February 2021 |
| Primary completion | 18 February 2021 |
| Estimated completion | 18 February 2021 |
Drugs / interventions tested
- Nivolumab (nivolumab) — full drug profile →
- Sapanisertib — full drug profile →
Conditions studied
- Lung Non-Small Cell Carcinoma — all drugs for Lung Non-Small Cell Carcinoma →
- Recurrent Lung Non-Small Cell Carcinoma — all drugs for Recurrent Lung Non-Small Cell Carcinoma →
- Stage I Lung Cancer AJCC v8 — all drugs for Stage I Lung Cancer AJCC v8 →
- Stage II Lung Cancer AJCC v8 — all drugs for Stage II Lung Cancer AJCC v8 →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Lung Non-Small Cell Carcinoma or Recurrent Lung Non-Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase I/II trial studies the side effects of sapanisertib and nivolumab and to see how well they work in treating patients with stage I-IV non-small cell lung cancer whose disease got worse on previous PD-1/PD-L1 inhibitor therapy. Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sapanisertib and nivolumab may help to control the disease.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Macropinocytosis and Vascularization Determine Response to mTOR Inhibitors in Lung Squamous Cell Carcinoma.
Brady MR, Matulionis N, Christofk HR, Garon EB, et al · · 2026 · PMID 41364715 · DOI 10.1158/0008-5472.can-25-0921
Verify or expand the search:
- PubMed search for NCT05022394
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05022394 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 27 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05022394.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing