Obstructive Sleep Apnea Influences Efficacy of PD-1-Based Immunotherapy Against Non-Small Cell Lung Cancer

NCT04743752 | Unknown DMC

• 1 other identifier: 2020-405
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, observational cohort study aims to explore the influence of obstructive sleep apnea(OSA) on the efficacy of PD-1-based immunotherapy in patients with non-small cell lung cancer(NSCLC). Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited. According to sleep monitor results, participants will be divided into Group NSCLC and Group OSA+NSCLC. Primary outcome is the objective remission rate(ORR).

Conditions

Obstructive Sleep Apnea; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  ORR, the percentage of complete response (CR) or partial response (PR) according to RECIST 1.1 standard definition.CR: disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker level; or reduction in short axis of any pathological lymph nodes (whether target or non-target) to less than (\<) 10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters; or persistence of one or more non-target lesion(s) and/or (if applicable) maintenance of tumor marker level above the normal limits.

  From date of randomization until the date of first documented progression, assessed up to 48 months

Secondary Outcomes (10)

• Progression-Free Survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Overall survival (OS)

  From date of randomization until the date of death from any cause, assessed up to 48 months

• Compared the baseline sleep monitor results between Group NSCLC and Group OSA+NSCLC.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Factors associated with ORR in NSCLC patients

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

• Factors associated with OS and PFS in NSCLC patients

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months

Study Arms (2)

Group OSA+NSCLC

According to the baseline sleep monitor results, participants will be divided into Group OSA+NSCLC if apnea hypopnea index(AHI) no less than 15.

Group NSCLC

According to the baseline sleep monitor results, participants will be divided into Group NSCLC if apnea hypopnea index(AHI) less than 15.

Eligibility Criteria

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

Study Population

Patients who had no prior treatment for advanced NSCLC and are intended to receive PD-1/PD-L1 antibody will be recruited and followed for 4 years.

You may qualify if:

• Histologically or cytologically confirmed, advanced NSCLC
• Participants with no prior treatment for advanced NSCLC
• Measurable disease as defined by RECIST v1.1
• Eligible to receive first-line treatment including PD-1 antibody
• Adequate hematologic and end organ function

You may not qualify if:

• Severe infection within 4 weeks prior to recruitment.
• Significant organ dysfunction or other serious diseases.
• Previous or current OSA related treatment, including oral appliance, surgery, mechanical ventilation therapy.
• Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

fecal and peripheral blood specimens

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases

Study Officials

• Jing Ma, MD

  Peking University First Hospital

  STUDY CHAIR

• Guangfa Wang, MD

  Peking University First Hospital

  STUDY DIRECTOR

• Yuan Cheng

  Peking University First Hospital

  STUDY DIRECTOR

• Ligong Nie

  Peking University First Hospital

  STUDY DIRECTOR

Central Study Contacts

Jing Ma, MD

CONTACT

+8613651357974; majjmail@163.com

Guangfa Wang, MD

CONTACT

+8613810644029; wangguangfa@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.&MD

Study Record Dates

• First Submitted: January 30, 2021
• First Posted: February 8, 2021
• Study Start: February 23, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)