Rationale and design for a phase IIIb trial of first-line tremelimumab plus durvalumab versus pembrolizumab, in combination with chemotherapy, in patients with non-squamous metastatic non-small-cell lung cancer and mutations or co-mutations in , or : the TRITON study.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
환자: non-squamous mNSCLC and mutations or co-mutations in , or
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
[DISCUSSION] Results will help to inform clinical practice and establish a biomarker-driven treatment strategy for these subtypes of mNSCLC with high unmet need. [TRIAL REGISTRATION] ClinicalTrials.gov identifier: NCT06008093 (registration date: August 17, 2023).
[BACKGROUND] Metastatic non-small-cell lung cancers (mNSCLC) harboring mutations in or are associated with an immunosuppressive tumor microenvironment and reduced responsiveness to PD-(L)1 inhibitor
APA
Skoulidis F, Borghaei H, et al. (2025). Rationale and design for a phase IIIb trial of first-line tremelimumab plus durvalumab versus pembrolizumab, in combination with chemotherapy, in patients with non-squamous metastatic non-small-cell lung cancer and mutations or co-mutations in , or : the TRITON study.. Therapeutic advances in medical oncology, 17, 17588359251386611. https://doi.org/10.1177/17588359251386611
MLA
Skoulidis F, et al.. "Rationale and design for a phase IIIb trial of first-line tremelimumab plus durvalumab versus pembrolizumab, in combination with chemotherapy, in patients with non-squamous metastatic non-small-cell lung cancer and mutations or co-mutations in , or : the TRITON study.." Therapeutic advances in medical oncology, vol. 17, 2025, pp. 17588359251386611.
PMID
41209621
Abstract
[BACKGROUND] Metastatic non-small-cell lung cancers (mNSCLC) harboring mutations in or are associated with an immunosuppressive tumor microenvironment and reduced responsiveness to PD-(L)1 inhibitor-based therapy, which is particularly notable when these genes are co-mutated with each other or with . Patients with these mNSCLC subtypes may benefit from combinations including cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitors, aimed at enhancing immune responses.
[OBJECTIVES] TRITON is an ongoing study comparing tremelimumab plus durvalumab and chemotherapy with pembrolizumab plus chemotherapy as first-line treatment for patients with non-squamous mNSCLC and mutations or co-mutations in , or .
[DESIGN] Phase IIIb, multicenter, open-label, two-arm parallel randomized trial.
[METHODS AND ANALYSIS] Approximately 280 eligible patients, aged ⩾18 years, will be randomized 1:1 to receive tremelimumab 75 mg plus durvalumab 1500 mg plus carboplatin AUC 5/6 or cisplatin 75 mg/m and pemetrexed 500 mg/m every 3 weeks (Q3W) for four cycles, followed by maintenance durvalumab 1500 mg plus pemetrexed 500 mg/m Q4W, with an additional dose of tremelimumab 75 mg at week 16 and optional further dose at month 24; or pembrolizumab 200 mg plus carboplatin AUC 5/6 or cisplatin 75 mg/m and pemetrexed 500 mg/m Q3W for four cycles, followed by maintenance pembrolizumab 200 mg plus pemetrexed 500 mg/m Q3W. Dual primary endpoints are overall survival (OS) in all randomized patients and OS in patients with or mutations or co-mutations. Key secondary endpoints include 12- and 24-month OS rates, progression-free survival, objective response rate, and safety. Enrollment is ongoing.
[ETHICS] TRITON will be approved by the independent ethics committee or institutional review board at each study site. All participants will provide written informed consent.
[DISCUSSION] Results will help to inform clinical practice and establish a biomarker-driven treatment strategy for these subtypes of mNSCLC with high unmet need.
[TRIAL REGISTRATION] ClinicalTrials.gov identifier: NCT06008093 (registration date: August 17, 2023).
[OBJECTIVES] TRITON is an ongoing study comparing tremelimumab plus durvalumab and chemotherapy with pembrolizumab plus chemotherapy as first-line treatment for patients with non-squamous mNSCLC and mutations or co-mutations in , or .
[DESIGN] Phase IIIb, multicenter, open-label, two-arm parallel randomized trial.
[METHODS AND ANALYSIS] Approximately 280 eligible patients, aged ⩾18 years, will be randomized 1:1 to receive tremelimumab 75 mg plus durvalumab 1500 mg plus carboplatin AUC 5/6 or cisplatin 75 mg/m and pemetrexed 500 mg/m every 3 weeks (Q3W) for four cycles, followed by maintenance durvalumab 1500 mg plus pemetrexed 500 mg/m Q4W, with an additional dose of tremelimumab 75 mg at week 16 and optional further dose at month 24; or pembrolizumab 200 mg plus carboplatin AUC 5/6 or cisplatin 75 mg/m and pemetrexed 500 mg/m Q3W for four cycles, followed by maintenance pembrolizumab 200 mg plus pemetrexed 500 mg/m Q3W. Dual primary endpoints are overall survival (OS) in all randomized patients and OS in patients with or mutations or co-mutations. Key secondary endpoints include 12- and 24-month OS rates, progression-free survival, objective response rate, and safety. Enrollment is ongoing.
[ETHICS] TRITON will be approved by the independent ethics committee or institutional review board at each study site. All participants will provide written informed consent.
[DISCUSSION] Results will help to inform clinical practice and establish a biomarker-driven treatment strategy for these subtypes of mNSCLC with high unmet need.
[TRIAL REGISTRATION] ClinicalTrials.gov identifier: NCT06008093 (registration date: August 17, 2023).