Small-cell Lung Cancer
Conditions
Brief summary
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.
Interventions
5mg/kg , every 3 weeks
DRUGplacebo for QL1604
every 3 weeks
DRUGQL1604
200mg, every 3 weeks
DRUGplacebo for Iparomlimab and Tuvonralimab (QL1706)
every 3 weeks
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | up to 2 years | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after chemoradiotherapy (CRT) for patients with LS-SCLC as measured by Blinded Independent Review Committee (BIRC)-assessed PFS |
| Overall survival (OS) | up to 5 years | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by OS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease control rate (DCR) | up to 2 years | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by DCR |
| duration of response (DoR) | up to 2 years | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by DoR |
| 2-year OS rate | up to 2 years | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by 2-year OS rate |
| 1-year OS rate | up to 1 year | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by 1-year OS rate |
| adverse events | up to 2 years | To compare and evaluate the safety of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by the incidence of adverse events (Percentage of participants with treatment-related adverse events as assessed by CTCAEv5.0.) and abnormal laboratory parameters. |
| PFS | up to 2 years | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by Investigator-assessed PFS |
| objective response rate (ORR) | up to 2 years | To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by ORR |
Contacts
Primary ContactZekai Yu, bachelor's degree
Outcome results
None listed