A Study to Evaluate Camrelizumab Combined With Famitinib as Subsequent Therapy in Patients With Advanced NSCLC

A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer Who Progressed on Prior Immune Checkpoint Inhibitor Treatment and Platinum-Based Chemotherapy

This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate versus docetaxel as subsequent therapy in Advanced NSCLC.

Study Overview

• Status: Terminated
• Conditions: Advanced NSCLC
• Intervention / Treatment: Drug: camrelizumab + famitinib; Drug: famitinib; Drug: docetaxel

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China, 225001
      • Subei People's Hospital of Jiangsu province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer.
2. Failed previous platinum-based chemotherapy and anti-PD-(L)1 monoclonal antibody treatment.
3. Have measurable disease based on RECIST v1.1.
4. ECOG PS score: 0-1.
5. Expected survival ≥ 3 months.
6. Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and until 6 months after the last study dose.
7. Subjects must participate voluntarily, sign the ICF, have good compliance, and cooperate with follow-up visits.

Exclusion Criteria:

1. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
2. Have known history of prior malignancy in the past 3 years.
3. Have active pulmonary tuberculosis.
4. Have clinical symptoms of the heart or heart diseases that are not well controlled.
5. Have hypertension which cannot be well controlled by antihypertensives
6. Urinalysis has indicated that the urine protein is ≥ ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is > 1.0 g.
7. Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
8. Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1.
9. Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
10. Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.
11. Previous treatment with camrelizumab, docetaxel, and small-molecule VEGFR inhibitors including famitinib.
12. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm A; camrelizumab + famitinib	Drug: camrelizumab + famitinib; camrelizumab for intravenous injection; famitinib malate capsules for oral administration
Experimental: Treatment Arm C; famitinib	Drug: famitinib; famitinib malate capsules for oral administration
Active Comparator: Treatment Arm B; docetaxel	Drug: docetaxel; docetaxel for intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS is the time interval from the date of randomization to death due to any reason or lost of follow-up.	up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first.	up to 4 years
ORR	Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points.	up to 4 years
DoR	Duration of Response, determined using RECIST v1.1 criteria.	up to 4 years
DCR	Disease Control Rate, determined using RECIST v1.1 criteria.	up to 4 years
TTF	Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.	up to 4 years

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2022
• Primary Completion (Actual): May 11, 2022
• Study Completion (Actual): May 11, 2022

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: SHR-1210-III-332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No