This single-arm, open-label, Phase II study assesses first-line QL1706 (iparomlimab and tuvonralimab, an anti-PD-1/CTLA-4 bispecific antibody) combined with platinum-based chemotherapy to treat patients with treatment-naïve, locally advanced or metastatic, SMARCA4-deficient non-small cell lung cancer (NSCLC).
The main questions it aims to answer are:Evaluate the efficacy and safety of this combination regimen in this specific patient population. Explore correlations between tumor molecular characteristics, the immune microenvironment, and treatment efficacy or toxicity.
Participants must:
Have histologically or cytologically confirmed, treatment-naïve, locally advanced or metastatic non-small cell lung cancer (NSCLC) with SMARCA4 deficiency. Be willing to provide archived or fresh tumor tissue samples. If unavailable, enrollment may proceed per investigator assessment. Have at least one measurable lesion per RECIST v1.1.
Voluntary participation and provision of signed written informed consent.
Age ≥ 18 years.
Life expectancy ≥ 3 months.
Histologically or cytologically confirmed diagnosis of Stage IIIB-IV lung cancer that is not amenable to curative surgery or radiotherapy.
Pathological diagnosis containing a small cell component.
Symptomatic brain metastases.
Leptomeningeal metastases.
Recurrence within 6 months after completing prior adjuvant therapy (if applicable).
Single group
QL1706, nab-paclitaxel, carboplatin
DrugParticipants will receive QL1706 (5 mg/kg, IV, day 1) in combination with nab-paclitaxel (260 mg/m², IV, day 1) and carboplatin (AUC=4-5, IV, day 1) every 21 days for 4-6 cycles. Dose adjustments may be made based on clinical judgment. Patients who do not experience disease progression or intolerable toxicity will proceed to maintenance therapy with QL1706 (5 mg/kg, IV, day 1) every 21 days. Treatment will continue until disease progression, unacceptable toxicity, consent withdrawal, investigator decision, loss to follow-up, death, or meeting other protocol-defined criteria for discontinuation. The maximum duration of QL1706 treatment is 24 months, after which continuation will be at the investigator's discretion based on individual benefit-risk assessment.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study treatment to the first documentation of disease progression according to RECIST v1.1 (as assessed by investigators) or death from any cause, whichever occurs first. Subjects who are alive without progression at the time of analysis will be censored at the date of the last tumor assessment.
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last follow-up.
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as per RECIST v1.1.
Duration of Response (DoR)
DoR is defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death.
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects who achieve CR, PR, or stable disease (SD) as their best overall response.
Immune-Related Adverse Events (irAEs)
Occurrence and grade of immune-related adverse events as defined by pre-specified criteria, including rash, colitis, hepatitis, endocrinopathies, and pneumonitis.
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Zhijie Wang
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Hebei Medical University Fourth Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
