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Efficacy and safety of Aipalolitoworilimab combined with docetaxel in the treatment of driver gene-negative mNSCLC after failure of first-line chemotherapy combined with immunotherapy: A prospective, single-arm clinical study

Efficacy and safety of Aipalolitoworilimab combined with docetaxel in the treatment of driver gene-negative mNSCLC after failure of first-line chemotherapy combined with immunotherapy: A prospective, single-arm clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121552
Enrollment
Unknown
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary lung cancer

Interventions

Experimental group:Aipalolitoworilimab combined with docetaxel

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75, no gender restriction; 2. Metastatic non-small cell lung cancer confirmed by pathological histology or cytology, with negative results for driver gene testing after genetic testing; 3. Previously failed combined chemotherapy and immunotherapy; 4. According to the Response Evaluation Criteria In Solid Tumors (RECIST 1.1), there must be at least one measurable lesion. 5. ECOG score 0-2; 6. Expected survival period >= 12 weeks. 7. All observed patients have voluntarily signed the informed consent for experimental treatment and can understand and comply with the study requirements to complete the research.

Exclusion criteria

Exclusion criteria: 1. Has a history of drug allergies; 2. Previous bispecific antibody therapy; 3. Active leptomeningeal metastases, brain metastases, or spinal cord compression. Unless the patient's disease is stable (asymptomatic; no evidence of new or progressive brain metastases), corticosteroid therapy must be discontinued for at least 14 days prior to the start of treatment. For patients with brain metastases who have received radiation therapy and/or surgery, a waiting period of 28 days after the intervention is required, and disease stability must be confirmed by imaging assessment prior to enrollment. 4. Has had other malignant tumors in the past 5 years, except for those that have been cured; 5. Has a history of immunodeficiency, or suffers from other acquired or congenital immunodeficiency diseases, or has a history of organ transplantation; 6. Combine history of myocardial infarction, history of heart failure, and active infection; 7. Pregnant, pre-pregnant, and lactating women; 8. Researchers evaluate patients with poor compliance who cannot guarantee treatment and follow-up according to the study protocol.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective Response Rate;Overall Survival;Disease Control Rate,DCR;

Countries

China

Contacts

Public ContactTang Hong

Henan Cancer Hospital

852261201@qq.com+86 371 6558 7013

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026