NCT06789796

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
636

participants targeted

Target at P75+ for phase_3

Timeline
47mo left

Started Feb 2025

Longer than P75 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Feb 2025Mar 2030

First Submitted

Initial submission to the registry

January 17, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

February 11, 2025

Status Verified

January 1, 2025

Enrollment Period

3.1 years

First QC Date

January 17, 2025

Last Update Submit

February 7, 2025

Conditions

Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression-free survival (PFS)

    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

    up to 2 years

  • Overall survival (OS)

    To compare and evaluate the efficacy of QL1706 versus QL1604 as consolidation therapy after CRT for patients with LS-SCLC as measured by OS

    up to 5 years

Secondary Outcomes (7)

  • objective response rate (ORR)

    up to 2 years

  • disease control rate (DCR)

    up to 2 years

  • duration of response (DoR)

    up to 2 years

  • PFS

    up to 2 years

  • 1-year OS rate

    up to 1 year

  • +2 more secondary outcomes

Study Arms (2)

QL1706 group

EXPERIMENTAL

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

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

QL1604 group

ACTIVE COMPARATOR

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

Drug: QL1604Drug: placebo for Iparomlimab and Tuvonralimab (QL1706)

Interventions

Iparomlimab and Tuvonralimab (QL1706)DRUG

5mg/kg , every 3 weeks

QL1706 group
placebo for QL1604DRUG

every 3 weeks

QL1706 group
QL1604DRUG

200mg, every 3 weeks

QL1604 group
placebo for Iparomlimab and Tuvonralimab (QL1706)DRUG

every 3 weeks

QL1604 group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Zekai Yu, bachelor's degree

CONTACT

18611428367zekai.yu@qilu-pharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2025

First Posted

January 23, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2030

Last Updated

February 11, 2025

Record last verified: 2025-01