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

A Phase II Study of the Efficacy and Safety of SHR-A1921 or SHR-A2009 in Patients With Previously Treated Advanced NSCLC

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.

Study Overview

• Status: Not yet recruiting
• Conditions: NSCLC
• Intervention / Treatment: Drug: SHR-A2009; Drug: SHR-A1921

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qiming Wang, professor; Phone Number: 13783590691; Email: qimingwang1006@126.com
• Study Contact Backup: Name: Zhen He, Professor; Phone Number: 13523530961; Email: hezhenriver@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
      • Contact: Qiming Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Voluntary participation and written informed consent;
2. Aged 18-75 years (inclusive), males and females;
3. Has a histologically or cytologically confirmed diagnosis of metastatic NSCLC (according to 8th AJCC/UICC Classification);
4. Has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy;
5. Has at least 1 measurable lesion per RECIST 1.1;
6. Patients with ECOG score of 0-1;
7. Life expectancy ≥12 weeks;
8. Have adequate organ function;
9. 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.

Exclusion Criteria:

1. Histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components;
2. Untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression;
3. Cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms;
4. Subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment;
5. Has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy；
6. Has a history of a second malignancy;
7. Has a history of non-infectious ILD/pneumonitis that required steroids, or has current ILD/pneumonitis;
8. Subjects with active pulmonary tuberculosis infection；
9. Serious infection before the first dose；
10. Uncontrolled cardiac diseases or symptoms;
11. Arterial/venous thrombosis events occurred before the first dose；
12. Hypertension that can not be well controlled through antihypertensive drugs，previous hypertensive crisis or hypertensive encephalopathy；
13. Has a history of active chronic enteritis;
14. Has a history of bleeding prior to the initiation of the study treatment;
15. History of immunodeficiency disease or organ transplant;
16. Subjects with active hepatitis B or active hepatitis C;
17. Has unresolved toxicities from previous anticancer therapy;
18. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-A1921or SHR-A2009;
19. Subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group 1; SHR-A2009	Drug: SHR-A2009; Treatment group: Subjects will receive an intravenous infusion of SHR-A2009 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
Experimental: Treatment group 2; SHR-A1921	Drug: SHR-A1921; Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR)	Assessed by Investigator According to RECIST v1.1	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS)	Assessed by Investigator According to RECIST v1.1	up to 12 months
overall survival (OS)	OS is the time from the date of first dose until the date of death by any cause.	up to 24 months
Duration of response(DoR )	Assessed by Investigator According to RECIST v1.1	up to 12 months
Disease control rate (DCR)	Assessed by Investigator According to RECIST v1.1	up to 12 months
Time to Response (TTR)	Assessed by Investigator According to RECIST v1.1	up to 12 months
The incidence and severity of adverse events (AEs)	Rated based on CTCAE V5.0	from Day1 to 90 days after last dose

Collaborators and Investigators

• Sponsor: Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

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
• Other Study ID Numbers: NSCLC-IIT-SHRA2009-SHRA1921

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