PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC (NCT07416058) | Clinical Trial Compass
Not Yet RecruitingPhase 2
PHOENIX: QL1706 Plus Chemotherapy and Bevacizumab in AGA-Resistant, PD-L1 ≥50% Non-Squamous NSCLC
61 participantsStarted 2026-01-31
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The study will enroll adult patients (aged 18-75 years) with histologically confirmed locally advanced or metastatic NSCLC (AJCC 9th Edition, Stage IIIB-IVB), and harbor confirmed actionable driver mutations for which targeted therapies are available; these mutations are stratified as follows: EGFR (19del, L858R); ALK, ROS1, RET fusions; KRAS G12C; BRAF V600; and HER2 exon 20 insertions. Patients must have disease progression following at least one line of TKI therapy and a 2-week washout period is required for prior TKI therapy or chemotherapy. Prior immunotherapy is not permitted. PD-L1 tumor proportion score (TPS) ≥ 50%, as confirmed by central laboratory testing using the 22C3 or SP263 clone on fresh or archival tumor tissue (collected within 2 years). Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, and presence of at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Exclusion Criteria:
* Prior treatment with QL1706 or other investigational PD-1/PD-L1/CTLA-4 antibodies, unless allowed by the protocol.
* Untreated or symptomatic central nervous system (CNS) metastases. Participants with previously treated, stable, and asymptomatic CNS metastases off steroids for at least 2 weeks before first dose may be eligible.
* History of severe allergic reactions or hypersensitivity to monoclonal antibodies, platinum agents, pemetrexed, bevacizumab, or any excipients o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR) per RECIST 1.1
Timeframe: From first dose until disease progression or start of new anti-cancer therapy, up to approximately 24 months.