Neoadjuvant PD-1 Inhibitor (Sintilimab), Anlotinib Combined With Chemotherapy in Resectable Stage IIA-IIIB NSCLC

NCT ID: NCT05400070

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2026-12-30

Brief Summary

primary purpose：Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.

Detailed Description

primary purpose：Observe the pathological complete response rate (PCR) of postoperative tumor tissue resection and evaluate the safety of the treatment process.

Description of the study design This is a single-center, prospective, open-label, single-arm clinical study to preliminarily explore the single-arm clinical study administration and drug management of Sintilimab, anlotinib combined with neoadjuvant chemotherapy in stage IIA-IIIB NSCLC

Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.

Conditions

Sintilimab; Lung Cancer; Anlotinib; Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

neoadjuvant therapy

Sintilimab (200mg fixed dose) iv, d1, q3w，anlotinib 10mg, po, qd1-14, q3w combine with Chemotherapy

Group Type: EXPERIMENTAL

Neoadjuvant therapy 1

Intervention Type: DRUG

Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.

Interventions

Neoadjuvant therapy 1

Dosing regimen Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w, was evaluated after 3 cycles of chemotherapy and stopped for 3 weeks (21 days) after surgery for 4-6 weeks (21-42 days) after the last dose.

Intervention Type: DRUG

Other Intervention Names

anlotinib 10mg, po, qd1-14, q3w; Chemotherapy; Sintilimab (200mg fixed dose) iv, d1, q3w

Eligibility Criteria

Inclusion Criteria

1. pathological diagnosis of lung cancer, Age 18 years and 75 years old, physical strength status score 0-1;

2. The investigator believes that the subject can comply with the study protocol;

3. The investigator has confirmed to have at least one measurable lesion according to the RECIST1.1 criteria;

4. Stage IIA, IIB, IIIA, IIIB NSCLC with histological or cytology proven operable treatment according to the International Association for Lung Cancer Research and the American Joint Committee on Cancer Staging version 8;

5. Good hematopoietic function, defined as absolute neutrophil number 1.5X109 / L (no granulocyte colony stimulating factor support therapy), platelet count 100X109 / L, hemoglobin 90 g / L; (no transfusion or no erythropoietin dependence within 7 days);

6. Good liver function, defined as 1.5 times the normal limit (ULN) of serum total bilirubin; ULN at 2.5 times transaminase (AST) and ALT); AST and ALT for recorded ULN;

7. Good renal function, defined as serum creatinine 1.5 times ULN or calculated creatinine clearance of 60 ml/min (Cockcroft-Gault formula); routine urine protein less than 2 +, or 24h urine protein <1g;

8. Good coagulation function, defined as the international standardized ratio (INR) or prothrombin time (PT) 1.5 times ULN;

9. The total amount of lung function (e. g., FVC, FEV1, TLC, FRC, and DLco) can tolerate the proposed lung resection procedure;

10. For female subjects of childbearing age, the urine or serum pregnancy test should be negative within 3 days before receiving the first dose (cycle 1, day 1)

Exclusion Criteria

1 . Presof locally advanced unresectable or metastatic disease;

2.. peripheral neuropathy;

3.Active, known or suspected autoimmune diseases, type I diabetes, hypothyroidism that requires only hormone replacement therapy, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or diseases not expected to recur without external stimulus factors can be selected;

4. Systemic treatment with corticosteroids (an equivalent dose of> 10 mg prednisone per day) or other immunosuppressive drugs within 14 days before randomization.Inhalor topical steroids are permitted without active autoimmune disease.

5.Active Hepatitis B / hepatitis C infection and known HIV;

6.Patients who have previously received chemotherapy or any other anti-tumor therapy;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tangdu Hospital, the Air Force Military University

Xi'an, , China

Countries

China

References

Duan H, Shao C, Luo Z, Wang T, Tong L, Liu H, Yao X, Lei J, Zhao J, Gao Y, Jiang T, Yan X. Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial). Signal Transduct Target Ther. 2024 Oct 28;9(1):296. doi: 10.1038/s41392-024-01992-0.

Reference Type: DERIVED

PMID: 39465257 (View on PubMed)

Other Identifiers

K202104-03

Identifier Type: -

Identifier Source: org_study_id