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

NCT07416058 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

All cohorts will receive the same treatment regimen in 3-week cycles.Participants will receive combination therapy, consisting of QL1706 (5.0 mg/kg, day 1), bevacizumab (7.5 mg/kg, days1), pemetrexed(500 mg/m², days1) and Platinum \[Cisplatin (75 mg/m²) or Carboplatin (AUC 5/mg/ml, up to 750 mg), Day 1\],intravenously every 3 weeks for four cycles in induction phase, followed by QL1706 (5.0 mg/kg, day 1) and bevacizumab (7.5 mg/kg, days1) every 3 weeks for up to 2 years or until disease progression

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Guangdong Association of Clinical Trials

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07416058 on ClinicalTrials.gov