CHIO3 Trial: CHemotherapy Combined With Immune Checkpoint Inhibitor for Operable Stage IIIA/B Non-Small Cell Lung Cancer

NCT04062708 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AFT-46
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 9

Brief Summary

This is a single arm, phase II trial of combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles for patients with potentially resectable stage IIIA and IIIB (T1-3, N2) NSCLC (per the 8th International Association for the Study of Lung Cancer classification). The primary objective of this study is to increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction therapy from historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.

Conditions

Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

Keywords

Stage IIIA/IIIB (T1-3,N2) Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• N2 nodal clearance (N2NC)

  To increase N2 nodal clearance (N2NC) to 50% or greater for combined platinum doublet chemotherapy with durvalumab induction from an historical rate of 30% for platinum doublet chemotherapy alone in patients with potentially resectable stage IIIA/B (N2) NSCLC.

  5 years

Secondary Outcomes (7)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  5 years

• Radiographic response rate

  5 years

• Rate of major pathologic response and pathologic complete response

  16 weeks

• Evaluate event free survival (EFS)

  5 years

• Overall survival rate

  5 years

Study Arms (1)

Treatment

EXPERIMENTAL

Combined neoadjuvant platinum doublet chemotherapy plus durvalumab followed by surgery, postoperative radiation and adjuvant durvalumab for 13 cycles.

Drug: Durvalumab; Procedure: Surgery; Radiation: Radiotherapy

Interventions

Durvalumab DRUG

Preoperative Treatment: * Non-squamous NSCLC: durvalumab 1125 mg, followed by pemetrexed 500 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles * Squamous NSCLC: durvalumab 1125 mg, followed by docetaxel 75 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles Adjuvant Therapy: • 1-6 weeks after completion of radiotherapy, durvalumab 1500 mg IV every 4 weeks will be administered for 13 cycles.

Also known as: Imfinzi

Treatment

Surgery PROCEDURE

Patients will be re-evaluated following preoperative treatment to assess if patient is still medically fit to withstand surgery. Eligible patients will then undergo lobectomy, bilobectomy, sleeve lobectomy or other extended resection, or a pneumonectomy will be performed at the discretion of the attending thoracic surgeon.

Treatment

Radiotherapy RADIATION

4-10 weeks after surgery, patients will receive 54 Gy of radiotherapy with single daily fractions.

Treatment

Eligibility Criteria

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

You may qualify if:

• Patients who are at least 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Life expectancy of at least 12 weeks.
• Patients with potentially resectable IIIA/B (T1-3, N2) NSCLC (per the 8th International Association for the Study of Lung Cancer classification) who are candidates for surgery with intent of R0 resection. Invasive T3 disease (eg, phrenic nerve, pericardium, chest wall other than Pancoast superior sulcus) may be included if the surgeon and study team deem it to be resectable. T4 disease per AJCC 8th edition staging system is excluded given the lack of benefit of surgery in T4N2.
• Patients must be evaluated by a thoracic surgeon within 4 weeks of registration.
• Operability is defined as having adequate pulmonary, cardiac, renal, nutritional, musculoskeletal, neurologic, and cognitive capacity to undergo major pulmonary resection with acceptable morbidity and mortality.
• N2 nodes must be discrete (ie, not invading surrounding structures) and less than 3 cm in maximum diameter.
• Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
• Pathologically proven N2 disease within 4 weeks of registration. PET/CT positivity in the ipsilateral mediastinal nodes will not be sufficient to establish N2 nodal status. Mediastinal lymph node sampling biopsy is required pre-operatively by at least one of the following:
• Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA);
• Mediastinoscopy;
• Mediastinotomy (Chamberlain procedure);
• Endoscopic ultrasound guided node aspiration (EUS);
• Video-assisted thoracoscopy; OR
• Fine needle aspiration by image guidance.

You may not qualify if:

• Any prior treatment for NSCLC.
• Prior thoracic radiation.
• Patients with ≥Grade 2 peripheral neuropathy.
• Any active or history of autoimmune disease (including any history of inflammatory bowel disease) or history of a syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy.
• Patients requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \<10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Patients with previous malignancies (except nonmelanoma skin cancers, in situ bladder, gastric, breast, colon or cervical cancers/dysplasia) are excluded unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period.
• History of solid organ transplant.
• N3 nodal disease.
• Mixed small cell/NSCLC will be excluded.
• Pregnant or breastfeeding.
• History of allogenic organ transplantation.
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], active diverticulitis with the exception of diverticulosis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia.
• Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement.
• Any chronic skin condition that does not require systemic therapy.

Sponsors & Collaborators

• Alliance Foundation Trials, LLC.: lead
• AstraZeneca: collaborator

Study Sites (9)

NorthWestern University

Chicago, Illinois, 60611, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lowell General Hospital

Lowell, Massachusetts, 01854, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Baptist Cancer Center

Memphis, Tennessee, 38120, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab; Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Evanthia Galanis, MD

  Alliance Foundation Trials, LLC.

  PRINCIPAL INVESTIGATOR

• Linda Martin, MD, MPH

  University of Virginia

  STUDY CHAIR

• Jyoti Patel, MD

  University of Chicago

  STUDY CHAIR

• James Urbanic, MD

  University of California, San Diego

  STUDY CHAIR

• David Kozono, MD

  Alliance Foundation Trials, LLC.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 20, 2019
• Study Start: March 10, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)