Neoadjuvant Immunotherapy With Chemotherapy for Stage I-IIIB Non-Small Cell Lung Cancer Patients

Neoadjuvant Immunotherapy With Chemotherapy for the Treatment of Stage I-IIIB Non-Small Cell Lung Cancer (NSCLC): A Phase II Exploratory Study

A phase II, single-arm, open-label study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with PD-(L)1 inhibitor in stage I-IIIB NSCLC adult patients followed by adjuvant PD-(L)1 inhibitor treatment for up to 1 year

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: PD-1 inhibitor

Detailed Description

A phase II, single-arm, open-label study that assesses feasibility, safety and efficacy of combined neoadjuvant chemotherapy and immunotherapy with PD-1 inhibitor in stage I-IIIB NSCLC adult patients followed by adjuvant treatment for up to 1 year with PD-(L)1 inhibitor.

Two to three cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor will be administered before surgery, followed by another one to two cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor and PD-(L)1 inhibitor monotherapy for up to 1 year.

After completion of neoadjuvant therapy and before surgery, a tumor assessment will be done. Patients with stable disease or partial response may be considered for surgery.

The report imaging response and pathological response rate will be evaluated. Patients eligible for the trial are those with a histological diagnosis or cytologically proven operable and resectable non-small-cell lung cancer. The total number of patients to be included will be 60 from Chinese Academy of Medical Sciences (CAMS).

Accrual period of 2 years or until the inclusion of the last patient necessary to achieve the sample set in the protocol of 60 patients. After that all patients will be treated for up to 1 year with adjuvant immunotherapy and they will be followed during 3 years after adjuvant treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Junling Li; Phone Number: 861087788713; Email: lijunling@cicams.ac.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • China
      • Contact: Junling Li, PhD; Phone Number: +861087788713; Email: lijunling@cicams.ac.cn
      • Contact: Puyuan Xing, PhD; Phone Number: +861087788713; Email: xingpuyuan@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- 1.Histologically- or cytologically- documented NSCLC who present stage I (T≥4cm), IIA, IIB, IIIA, or IIIB disease, of either squamous or non-squamous histology.

2.Deemed surgically resectable by a thoracic surgeon 3.Age ≥ 18 years 4.Radiologically measurable disease, as defined by response evaluation criteria in solid tumours (RECIST) v1.1 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 6.Notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines.

Exclusion Criteria:

• 1. Carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene or other mutations predicting hyperprogression of immunotherapy.

  2. Active, known or suspected autoimmune disease. 3.Other active malignancy requiring concurrent intervention or with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast).

  4.Prior treatment with anti-PD-1, anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen (CTLA-4), or anti-PD-L1 therapeutic antibody or pathway-targeting agents 5.History of allergy to study drug components excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neoadjuvant PD-(L)1 inhibitor with chemotherapy followed by PD-(L)1 inhibitor for up to 1 year	Drug: PD-1 inhibitor; Two to three cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor will be administered before surgery, followed by another one to two cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor and PD-(L)1 inhibitor monotherapy for up to 1 year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPR (major pathologic response)	Major pathologic response (MPR) is defined as > 90 percent decrease in viable tumor.	Up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS(disease-free survival)	Time from first dose of neoadjuvant treatment to recurrence of tumor or death	at 3 years from the first dose of neoadjuvant treatment
OS(overall survival)	Time when the patient is still alive	at 3 years from the first dose of neoadjuvant treatment
Toxicity profile	Toxicities caused by the drug during the study，according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	from the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment

Collaborators and Investigators

• Sponsor: Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immune Checkpoint Inhibitors
• Other Study ID Numbers: NCC2873

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No