Clinical Study of SHR-A1921 or SHR-A2009 in Previously Treated Advanced NSCLC

NCT06465238 | Not Yet Recruiting Phase 2

• 1 other identifier: NSCLC-IIT-SHRA2009-SHRA1921
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label Phase II clinical trial to evaluate the safety and efficacy of SHR-A1921 or SHR-A2009 in patients with advanced NSCLC who progressed after standard therapy.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Assessed by Investigator According to RECIST v1.1

  up to 12 months

Secondary Outcomes (6)

• Progression-free survival (PFS)

  up to 12 months

• overall survival (OS)

  up to 24 months

• Duration of response(DoR )

  up to 12 months

• Disease control rate (DCR)

  up to 12 months

• Time to Response (TTR)

  up to 12 months

Study Arms (2)

Treatment group 1

EXPERIMENTAL

SHR-A2009

Drug: SHR-A2009

Treatment group 2

EXPERIMENTAL

SHR-A1921

Drug: SHR-A1921

Interventions

SHR-A2009 DRUG

Treatment group: Subjects will receive an intravenous infusion of SHR-A2009 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Treatment group 1

SHR-A1921 DRUG

Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

Treatment group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and written informed consent;
• Aged 18-75 years (inclusive), males and females;
• Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (according to 8th AJCC/UICC Classification);
• Has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy;
• Has at least 1 measurable lesion per RECIST 1.1;
• Patients with ECOG score of 0-1;
• Life expectancy ≥12 weeks;
• Have adequate organ function;
• Participants agrees to use contraception, and be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of study treatment.

You may not qualify if:

• Histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components;
• Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression;
• Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
• Subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment;
• Has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy；
• Has a history of a second malignancy;
• Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
• Subjects with active pulmonary tuberculosis infection；
• Serious infection before the first dose；
• Uncontrolled cardiac diseases or symptoms;
• Arterial/venous thrombosis events occurred before the first dose；
• Hypertension that can not be well controlled through antihypertensive drugs，previous hypertensive crisis or hypertensive encephalopathy；
• Has a history of active chronic enteritis;
• Has a history of bleeding prior to the initiation of the study treatment;
• History of immunodeficiency disease or organ transplant;

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan cancer hospital

Zhengzhou, Henan, China

Location

Central Study Contacts

Qiming Wang, professor

CONTACT

13783590691; qimingwang1006@126.com

Zhen He, professor

CONTACT

13523530961; hezhenriver@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)