Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, prospective, exploratory clinical study aiming to evaluate the efficacy and safety profile of sintilimab combined with anlotinib hydrochloride and platinum-containing dual-agent chemotherapy regimens in advanced or metastatic NSCLC as first-line treatment. Totally 40 patients with negative driver genes (20 patients of squamous cell carcinoma, 20 patients of non-squamous cell carcinoma) are to be enrolled.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Carboplatin; Cisplatin; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• 1. Voluntary provision of informed consent.

• 2. Males or females aged 18-75.

• 3. Histological or cytologically confirmed NSCLC, metastatic or recurrent (stage IV), non-resectable or radical radio-chemotherapy locally advanced (stage IIIB-IIIC).

• 4. Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, or ROS1 gene mutation)

• 5. At least one lesion can be measured by imaging.

• 6. Have not received systemic treatment in the past.

• 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.

• 8. Life expectancy ≥ 3 months.

• 9. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.

Exclusion Criteria:

• 1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.

• 2. Received radiation therapy within 6 weeks.

• 3. Diagnosed with other malignant diseases other than NSCLC within 5 years.

• 4. Have participated in other interventional clinical research treatments now or within 4 weeks.

• 5. Have previously received targeted therapy.

• 6. Received Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs within 2 weeks.

• 7. Have active autoimmune diseases requiring systemic treatment within 2 years.

• 8. Received systemic glucocorticoid therapy or immunosuppressive therapy within 7 days.

• 9. Clinically uncontrollable pleural effusion/abdominal effusion.

• 10. Known allogeneic organ transplantation or hematopoietic stem cell transplantation.

• 11. Known to be allergic to study drug.

• 12. Have been vaccinated with the live vaccine within 30 days.

• 13. Pregnant or breastfeeding females.

• 14. Other serious hazards to the safety of patients.