PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC

Study acronym: PHOENIX
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Notable Recruitment opened Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Dec 31, 2027 to Dec 30, 2027
    • Start date changed from estimate of Jan 31, 2026 to Apr 30, 2026
    • Eligibility criteria expanded, about 14 words
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
The goal of this Phase II clinical trial (The PHOENIX Study) is to evaluate if the combination of QL1706 (Iparomlimab and Tuvonralimab), bevacizumab, and chemotherapy can treat patients with TKI-refractory, driver-gene positive (e.g., EGFR, ALK, ROS1, RET, KRAS, BRAF, HER2), non-squamous non-small cell lung cancer (NSCLC) who have high PD-L1 expression (TPS ≥50%). The main question\[s\] it aims to answer \[is/are\]: Does the quadruple combination therapy improve the Objective Response Rate (ORR) compared to historical chemotherapy data? What are the secondary efficacy outcomes, including Progression-Free Survival (PFS) and Overall Survival (OS)? If there is a comparison group: There is no concurrent control group (this is an open-label, multi-cohort study). Researchers will compare the treatment outcomes of the participants to historical control data (standard platinum-based chemotherapy) to see if the objective response rate (ORR) improves from a historical baseline of 29% to a target of 55%. Participants will: Receive induction therapy every 3 weeks for 4 cycles, consisting of intravenous infusions of QL1706, bevacizumab, pemetrexed, and platinum chemotherapy (cisplatin or carboplatin). Receive maintenance therapy every 3 weeks with QL1706 and bevacizumab for up to 2 years or until disease progression. Undergo regular tumor assessments (CT or MRI scans) to monitor disease status according to RECIST v1.1 criteria. Provide blood samples for safety monitoring and potential biomarker analysis.
Trial Details
NCT Number NCT07416058
Lead Sponsor Guangdong Association of Clinical Trials
Collaborators: Qilu Pharmaceutical Co., Ltd.
Conditions
(from sponsor)
Lung Adenocarcinoma
Related terms Adenocarcinoma of Lung, Diabetes Mellitus, Insulin-Dependent, 12
Enrollment 61 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov