Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB

NCT05295212 | Recruiting Phase 2

• 1 other identifier: NATAL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy, safety, tolerability, feasibility of surgery, and incidence of preoperative and postoperative complications of atezolizumab in combination with platinum-based chemotherapy with resectable stage II-IIIB non-small cell lung cancer.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• MPR Rate

  Major pathological remissions

  1.5 year

• MRD negative Rate

  Minimal residual disease rate

  1.5 year

Secondary Outcomes (5)

• pCR

  1.5 year

• DFS

  1.5 year

• EFS

  1.5 year

• ORR

  1.5 year

• OS

  1.5 year

Study Arms (2)

Cohort A

NO INTERVENTION

MRD revealed negative

Cohort B

EXPERIMENTAL

MRD revealed positive

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

Pemetrexed (500mg/m2)/Paclitaxel (260mg/m2) Carboplatin (AUC=4-5) Atezolizumab(1200mg) ivgtt, every 21 days Range from 4 cycles

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects selected for this study must meet all of the following criteria:
• Sign written informed consent before implementing any trial-related procedures;
• Age ≥18 years old and ≤75 years old; No limit on the gender;
• Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter \< 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification;

You may not qualify if:

• Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1;
• Twenty tissue sections (4-6 microns in thickness) should be submitted before enrollment for biomarker evaluation (tumor tissue samples must be fresh or archival samples obtained within 3 months before enrollment; fresh tissues must be biopsy specimens by hollow needle aspiration, resection or incision);
• ECOG score 0-1;
• The total lung function can withstand the proposed pneumonectomy surgery according to the surgeon's assessment;
• Women should agree to use contraceptive measures (such as intrauterine device (IUD), contraceptives or condoms) during the study and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before study entry, and must be non-lactating patients; men should agree to use contraceptive measures during the study and within 6 months after the end of the study period.
• Subjects who meet the following criteria cannot be selected for this study:
• Histopathology is neuroendocrine carcinoma and sarcomatoid tumor；
• The presence of locally advanced unresectable or metastatic disease; unresectable including stage III non-small cell lung cancer multidisciplinary diagnosis and treatment expert consensus (2019 version) defined unresectable, including partial IIIA, IIIB and all IIIC, usually including single-station N2 mediastinal lymph nodes short diameter ≥ 3 cm or multi-station lymph nodes fused into a mass (CT lymph nodes short diameter ≥ 2 cm) N2, invading the esophagus, heart, aorta, pulmonary veins T4 and all N3;
• Subjects with known EGFR mutations or ALK, ROS1 translocations, non-squamous cell carcinoma subjects need to clarify the EGFR, ALK and ROS1 mutation status；
• Early stage NSCLC previously treated with systemic anticancer therapy, including treatment with investigational agents；
• History of (non-infectious) pneumonia/interstitial lung disease requiring steroid therapy, or current pneumonia/interstitial lung disease requiring steroid therapy；
• Known history of active tuberculosis;
• Known active infection requiring systemic treatment;
• Any known or suspected autoimmune disease or immunodeficiency subjects, except: patients with a history of hypothyroidism, if hormone therapy is not required, or are receiving physiological doses of hormone replacement therapy; subjects with stable type I diabetes whose blood glucose is controlled;
• Subjects with active hepatitis B (defined as positive hepatitis B virus surface antigen \[HBsAg\] test results and HBV-DNA test values higher than the upper limit of normal of the laboratory of the study site) or hepatitis C (defined as positive hepatitis C virus surface antibody \[HCsAb\] test results and positive HCV-RNA test results during the screening period);

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer hospital

Changsha, Hunan, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yongchang C Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong C Yang, MD

CONTACT

+8613873123436; yangnong0217@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 25, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)