Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer

• Sponsor: Hunan Province Tumor Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05296603
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 8.1
• Patients Per Site Per Month: 4.9

Study Details

Study Description

Brief Summary

This study aimed to explore the efficacy and biomarker explanation of IBI-322 Plus Lenvatinib on extensive stage small cell lung cancer who failed from first line Atezolizumab plus platinum based chemotherapy.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Biomarker Explanation of IBI-322 Plus Lenvatinib on Extensive Stage Small Cell Lung Cancer Who Failed From First Line Atezolizumab Plus Platinum Based Chemotherapy: A Phase I Perspective Study
• Anticipated Study Start Date: Jul 20, 2022
• Anticipated Primary Completion Date: Nov 10, 2022
• Anticipated Study Completion Date: Mar 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A Duration of response time more than 6 months	Drug: IBI-322 Plus Lenvatinib; IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg
Experimental: Cohort B Duration of response time between 3 and 6 months	Drug: IBI-322 Plus Lenvatinib; IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg
Experimental: Cohort C Duration of response time less than 3 months	Drug: IBI-322 Plus Lenvatinib; IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg

Outcome Measures

Primary Outcome Measures

1. ORR [1 year]

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

Secondary Outcome Measures

1. PFS [1year]

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

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:

• Age ≥ 18 years of age on day of signing informed consent.

• Pathological revealed extensive stage small cell lung cancer.

• Patients who failed from first line Atezolizumab plus platinum based chemotherapy

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: NCT05296603
• Other Study ID Numbers: BELIEVE
• 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; Small Cell Lung Carcinoma; Lenvatinib

Study Results

No Results Posted as of Jul 18, 2022