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

Sponsor

Tang-Du Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05400070

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neoadjuvent PD-1 Inhibitor Lung Cancer Anlotinib Chemotherapy	Drug: neoadjuvant PD-1 inhibitor, anlotinib combined with chemotherapy	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Single-arm Clinical Study to Investigate the Efficacy and Safety of Neoadjuvant PD-1 Inhibitor, Anlotinib Combined With Chemotherapy in Resectable Stage IIA-IIIB NSCLC

Anticipated Study Start Date :

May 30, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: neoadjuvant PD-1 inhibitor, anlotinib combined with chemotherapy neoadjuvant PD-1 inhibitor, anlotinib combined with chemotherapy	Drug: neoadjuvant PD-1 inhibitor, anlotinib combined with chemotherapy Sintilimab (200mg fixed dose) iv, d1, q3w + anlotinib 10mg, po, qd1-14, q3w+Chemotherapy

Arm

Intervention/Treatment

Experimental: neoadjuvant PD-1 inhibitor, anlotinib combined with chemotherapy

neoadjuvant PD-1 inhibitor, anlotinib combined with chemotherapy

Drug: neoadjuvant PD-1 inhibitor, anlotinib combined with chemotherapy

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

Outcome Measures

Primary Outcome Measures

pathological complete response (PCR) [up to 4 months]
pathological complete response (PCR)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 72 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

pathological diagnosis of lung cancer, Age 18 years and 75 years old, physical strength status score 0-1;
The investigator believes that the subject can comply with the study protocol;
The investigator has confirmed to have at least one measurable lesion according to the RECIST1.1 criteria;
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;
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);
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;
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;
Good coagulation function, defined as the international standardized ratio (INR) or prothrombin time (PT) 1.5 times ULN;
The total amount of lung function (e. g., FVC, FEV1, TLC, FRC, and DLco) can tolerate the proposed lung resection procedure;
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;

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tangdu Hospital, the Air Force Military University	Xi'an		China	710038

Sponsors and Collaborators

Tang-Du Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tang-Du Hospital

ClinicalTrials.gov Identifier:

NCT05400070

Other Study ID Numbers:

K202204-03

First Posted:

Jun 1, 2022

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tang-Du Hospital

Neoadjuvant pd-1 inhibitor Anlotinib chemotherapy safty efficacy

Additional relevant MeSH terms:

Immune Checkpoint Inhibitors

Study Results

No Results Posted as of Jun 1, 2022