A Phase II Study of QL1706 With Anti-angiogenesis Therapy and Chemotherapy in Extensive-stage Small Cell Lung Cancer.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhijie Wang

About this trial

This single-arm, open-label, Phase II study assesses first-line QL1706 + bevacizumab (anti-VEGF) + platinum/etoposide chemotherapy to treat naïve ES-SCLC patients.The main questions it aims to answer are:

Evaluate efficacy and safety of this quadruplet regimen in ES-SCLC Explore correlations between tumor biomarkers and treatment efficacy

Participants will:

Histologically or cytologically confirmed, treatment-naïve extensive-stage small cell lung cancer (ES-SCLC).

Willing to provide archived or fresh tumor tissue samples. If unavailable, enrollment may proceed per investigator assessment.

At least one measurable lesion per RECIST v1.1

Eligibility criteria

Qualifiers

Signed written informed consent and willingness to comply with study procedures.

Age ≥18 years.

Estimated life expectancy ≥3 months.

ECOG performance status of 0 or 1.

Disqualifiers

Prior chemotherapy, immunotherapy, targeted therapy, or radiotherapy.

Histologic or cytologic evidence of non-small cell or mixed small cell/non-small cell carcinoma.

Symptomatic brain metastases or leptomeningeal disease.

Active or suspected autoimmune disease, except for stable vitiligo, type 1 diabetes, hypothyroidism requiring only hormone replacement, or conditions not expected to recur.

Trial design

Treatments tested in this trial

  • QL1706 , bevacizumab, etoposide , cisplatin or carboplatin

Treatment groups

56 Participants
are divided into 1 treatment group

Sponsors and collaborators

Zhijie Wang

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Sponsor institution

Peking University Cancer Hospital & Institute

Collaborator

Hebei Medical University Fourth Hospital

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Renmin Hospital of Wuhan University

Collaborator

Wuhan TongJi Hospital

Collaborator

Peking University People's Hospital

Collaborator

Shanxi Province Cancer Hospital

Collaborator