Efficacy and Biomarker Explanation of IBI-322 +Lenvatinib Plus Platinum Based Chemotherapy on ALK-Rearranged NSCLC

• Sponsor: Hunan Province Tumor Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05296278
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20.4
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

This study aimed to explore the efficacy and biomarker explanation of IBI-322 combined with Lenvatinib plus platinum based chemotherapy on ALK-rearranged non-small cell lung cancer who failed from first line Alectinib.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: IBI-322 Plus Lenvatinib and Platinum	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Biomarker Explanation of IBI-322 + Lenvatinib Plus Platinum Based Chemotherapy on ALK-Rearranged Non-Small Cell Lung Cancer Who Failed From First Line Alectinib: A Phase I Perspective Study
• Anticipated Study Start Date: Jul 20, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A patients with only 3'ALK confirmed by NGS	Drug: IBI-322 Plus Lenvatinib and Platinum; IBI-322 combined with Lenvatinib (8mg/Kg) plus platinum based chemotherapy ivgtt, every 21 days until disease progression
Experimental: Cohort B patients with 3'ALK with retention of 5'ALK	Drug: IBI-322 Plus Lenvatinib and Platinum; IBI-322 combined with Lenvatinib (8mg/Kg) plus platinum based chemotherapy ivgtt, every 21 days until disease progression

Outcome Measures

Primary Outcome Measures

1. PFS [1 year]

   Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first)

Secondary Outcome Measures

1. ORR [1 year]

   Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects

2. OS [1 year]

   Defined as the time from the start of treatment to the death of the subject due to any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sign written informed consent before implementing any trial-related procedures;

• Patients diagnosed with Lung Adenocarcinoma ALK-Rearranged Stage IIIA-IV by pathology.

• Patients who failed from first line Alectinib with stable brain metastasis included (Radiotherapy treated Oligo-metastasis)

Exclusion Criteria:

• Patients with contraindication of chemotherapy Pregnant or breast feeding women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunan Cancer hospital	Changsha	Hunan	China

Sponsors and Collaborators

• Hunan Province Tumor Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yongchang Zhang, Director, Head of Medical Oncology, Principal Investigator, Clinical Professor, Hunan Province Tumor Hospital
• ClinicalTrials.gov Identifier: NCT05296278
• Other Study ID Numbers: REVERSE
• First Posted: Mar 25, 2022
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Lenvatinib

Study Results

No Results Posted as of Jul 18, 2022