a Study of QL1706 or QL1604 in Patients With Limited-stage Small Cell Lung Cancer After Chemoradiotherapy.

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 3

Conditions: Small-cell Lung Cancer

Treatments: Drug: placebo for QL1604; Drug: QL1604; Drug: Iparomlimab and Tuvonralimab (QL1706); Drug: placebo for Iparomlimab and Tuvonralimab (QL1706)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06789796

QL1706-310

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy and safety of QL1706 versus QL1604 monotherapy as consolidation treatment in patients with limited-stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after concurrent or sequential chemoradiotherapy.

QL1706 (Iparomlimab and Tuvonralimab) is a single bifunctional MabPair product against PD-1 and CTLA-4. QL1604 is a monoclonal antibody against PD-1.

Enrollment: 636 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient must be aged between 18 and 75 years (inclusive of boundary values), and both males and females are eligible.
• Pathologically confirmed LS-SCLC [I-III stage SCLC (any T, any N, M0)], according to the American Joint Committee on Cancer (AJCC, 8th edition) staging manual.
• Received 4 cycles of chemotherapy concurrent or sequential with radiotherapy. Chemotherapy must contain platinum and etoposide. Radiotherapy must be either total 60-70 Gy over 6 weeks for the QD regimen or total 45 Gy over 3 weeks for BID schedules.
• Patients must have achieved a complete response (CR), partial response (PR), or stable disease (SD) after receiving curative platinum-based CRT and must not have developed progressive disease (PD) prior to study entry.

Exclusion criteria

• Mixed SCLC and non-small cell lung cancer (NSCLC).
• Extensive-stage SCLC.
• Active or prior documented autoimmune or inflammatory disorders.
• Received other chemotherapy regimens besides etoposide and platinum-based therapy.
• Active or prior documented autoimmune or inflammatory disorders.
• Presence of interstitial lung disease or active non-infectious pneumonia (excluding grade 1 radiation pneumonitis not treated with corticosteroids).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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636 participants in 2 patient groups

QL1706 group

Experimental group

Description:

Iparomlimab and Tuvonralimab + placebo for QL1604, intravenous infusion (IV), every 3 weeks

Treatment:

Drug: Iparomlimab and Tuvonralimab (QL1706)

Drug: placebo for QL1604

QL1604 group

Active Comparator group

Description:

QL1604 + placebo for Iparomlimab and Tuvonralimab, IV, every 3 weeks

Treatment:

Drug: placebo for Iparomlimab and Tuvonralimab (QL1706)

Drug: QL1604