NCT05487391

A Study of QL1706 Combined With Platinum-containing Chemotherapy in Adjuvant Treatment of Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection.

Recruiting now Phase 3 Last updated 15 October 2024

What this trial tests

Phase 3 trial testing QL1706 injection in Carcinoma, Non-Small-Cell Lung in 632 participants. Currently enrolling.

Timeline

8 December 2022

Primary endpoint
31 August 2027

22 May 2029

Quick facts

Lead sponsor	Qilu Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	632
Start date	8 December 2022
Primary completion	31 August 2027
Estimated completion	22 May 2029
Sites	1 location across China

Drugs / interventions tested

• QL1706 injection
• Vinorelbine Tartrate
• Paclitaxel — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Carboplatin
• Pemetrexed — full drug profile →
• Placebo

Conditions studied

• Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →

Sponsor

Qilu Pharmaceutical Co., Ltd. — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage II-IIIB NSCLC without EGFR-sensitizing mutations and ALK fusions after complete surgical resection.The subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibodies to watch in 2024.
   Crescioli S, Kaplon H, Chenoweth A, Wang L, et al · · 2024 · cited 122× · PMID 38178784 · DOI 10.1080/19420862.2023.2297450
2. Dual blockade immunotherapy targeting PD-1/PD-L1 and CTLA-4 in lung cancer.
   Cheng W, Kang K, Zhao A, Wu Y. · · 2024 · cited 110× · PMID 39068460 · DOI 10.1186/s13045-024-01581-2
3. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors.
   Zhao Y, Ma Y, Zang A, Cheng Y, et al · · 2023 · cited 34× · PMID 37158938 · DOI 10.1186/s13045-023-01445-1
4. New systemic treatment paradigms in resectable non-small cell lung cancer and variations in patient access across Europe.
   Houda I, Dickhoff C, Uyl-de Groot CA, Reguart N, et al · · 2024 · cited 22× · PMID 38476748 · DOI 10.1016/j.lanepe.2024.100840
5. Adjuvant Immunotherapy for Resectable Non-Small Cell Lung Cancer: Current Advances and Future Perspectives.
   Ravasin A, Gatteschi L, Massa V, Iannopollo M, et al · · 2025 · cited 1× · PMID 40647398 · DOI 10.3390/cancers17132099
6. Progress in perioperative immunotherapy for lung cancer and analysis of therapy (Review).
   Ma X, Li G, Li H, Li L, et al · · 2026 · PMID 41560977 · DOI 10.3892/ol.2026.15453
7. Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors-A phase 1/1b study.
   Ma Y, Lin S, Chen Q, Xue J, et al · · 2025 · PMID 41045933 · DOI 10.1016/j.xcrm.2025.102396