TRITON：STK11/KEAP1/KRAS晚期NSCLC一线：标准化疗+：度伐利尤单抗+曲美木单抗 vs 帕博利珠单抗

III 期TRITON试验正在比较帕博利珠单抗联合标准化学免疫疗法与四药联合方案，即在化疗的基础上添加双重免疫检查点抑制剂度伐利尤单抗和曲美木单抗 ，在携带STK11、KEAP1或KRAS突变或共同突变的非鳞状转移性NSCLC患者中的疗效差异。据推测，这种组合疗法可以改善疗效，特别是对于PD-L1表达低的肿瘤患者和/或伴有STK11或KEAP1共同突变的肿瘤患者。
晚期STK11/KEAP1/KRAS非小细胞肺癌一线治疗 度伐利尤单抗和曲美木单抗+标准化疗 vs 帕博利珠单抗+标准化疗。

The phase 3b TRITON study（NCT06008093) will delve deeper into the effectiveness of a triplet regimen that encompasses immunotherapy of tremelimumab (anti–CTLA-4 and can block binding of CD80 and CD 86 to CD28) and durvalumab (anti–PD-L1 and can block binding of PD-L1 to PD-1 and CD80) plus standard-of-care (SOC) chemotherapy vs pembrolizumab and SOC chemotherapy for metastatic non–small lung cancer (NSCLC) harboring STK11 and/or KEAP1 and/or KRAS mutations.1 The trial will build on results seen in the phase 3 POSEIDON trial (NCT03164616), which investigated this same regimen in the first line vs durvalumab with chemotherapy or chemotherapy alone2; findings from the trial led to the approval of tremelimumab and durvalumab plus chemotherapy for NSCLC.

A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS (TRITON)
A Phase IIb, Randomized, Multicenter, Open-label Study to Assess the Efficacy of Durvalumab Plus Tremelimumab Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for First-line Treatment in Metastatic Non-small Cell Lung Cancer Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS (TRITON)The purpose of the study is to assess the efficacy of durvalumab plus tremelimumab in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy in metastatic NSCLC patients with non-squamous histology who have mutations and/or co-mutations in STK11, KEAP1, or KRAS.

Detailed Description

A trial to learn if durvalumab plus tremelimumab with chemotherapy is safe and how well it works compared to pembrolizumab with chemotherapy in participants with metastatic non-small cell lung cancer with certain genetic mutations.

INFORMATION FOR TRIAL PARTICIPANTS:

Researchers are looking for a better way to treat people who have metastatic NSCLC and tumors with STK11, KEAP1, or KRAS genetic mutations. Most people learn they have NSCLC after it has already become metastatic, and it can no longer be treated with surgery.

Based on previous trials, researchers think durvalumab plus tremelimumab with chemotherapy could help participants more than the current standard treatment, which is pembrolizumab with chemotherapy. Durvalumab and tremelimumab are designed to work by helping the immune system recognize and kill cancer cells.

In this trial, researchers want to learn more about how well durvalumab plus tremelimumab with chemotherapy works in people with metastatic NSCLC and genetic mutations that can cause the cancer to be less responsive to treatment.

This trial is planned to have 100 participants. These participants will be randomly divided into one of two groups:

• One group will receive durvalumab plus tremelimumab with standard of care chemotherapy
• One group will receive pembrolizumab with standard of care chemotherapy
  

Durvalumab, tremelimumab, pembrolizumab, and chemotherapy are given as an injection over time into a vein, also called an IV infusion. Chemotherapy will be one of the following regimens: pemetrexed plus cisplatin or pemetrexed plus carboplatin.

This is an open-label trial. This means that each participant will know which trial treatment they receive, and the doctors and trial staff will also know.

Researchers will measure and compare:

• How long participants live during the trial without their cancer getting worse
• How long participants live during the trial
• How many participants' tumors respond to treatment
• How long participants' tumor responses last
• How long before participants need to start a different treatment type
  

Researchers will also keep track of all the medical problems participants have during the trial and monitor their safety.

Participants will stop receiving trial treatment if they no longer benefit from it, at trial close, or if they stop participating for another reason.

Participants will visit their trial site every 3 to 4 weeks. At most visits, participants will:

• Have a physical exam and answer questions about any medications they are taking or any medical problems they have
• Receive their trial treatment
• Give blood and urine samples
• Have pictures of their tumors taken using CT or MRI scans