Chemotherapy Combined With Immunotherapy or Chemotherapy Combined With Immune Checkpoint Inhibitor Plus Bevacizumab in 5'-ALK NSCLC

• Sponsor: Hunan Province Tumor Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04997382
• Collaborator: (none)
• Enrollment: 598
• Location: 1
• Actual Duration (Months): 50.6
• Patients Per Site Per Month: 11.8

Study Details

Study Description

Brief Summary

This study was designed to explore the efficacy and safety of Alectinib as a first-line treatment for advanced NSCLC with ALK rearrangement positive mutation in the real world. On the basis of the hypothesis that the 5' partner influences the intrinsic properties of the fusion protein, immune surveillances that impact oncogenic potential, and sensitivity to ALK TKIs, the investigators investigated the clinical impact of the detection of non-reciprocal/reciprocal ALK translocations in ALK-rearranged NSCLC patients receiving alectinib as first- or subsequent-line therapy. The investigators also performed whole transcriptomic analysis by RNA sequencing and translated proteins identification by proteomics using tissue samples from patients with non-reciprocal/reciprocal ALK translocations and 3'-ALK fusion to identify certain differentially expressed genes or proteins and their signaling pathways.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: Alectinib

Study Design

• Study Type: Observational
• Actual Enrollment: 598 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Chemotherapy Combined With Immune Checkpoint Inhibitor or Chemotherapy Combined With Immune Checkpoint Inhibitor Plus Bevacizumab in 5'-ALK Rearranged Advanced NSCLC Patients
• Actual Study Start Date: Apr 14, 2017
• Actual Primary Completion Date: Jun 5, 2020
• Actual Study Completion Date: Jul 1, 2021

Outcome Measures

Primary Outcome Measures

1. PFS [may 2017- may 2021]

   progression survival time

Secondary Outcome Measures

1. OS [may 2017- may 2021]

   over survival time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology

• ALK Arranged Positive

• ALK Arranged Detection Method is NGS

• Treatment Plan is Alectinib 600mg po bid

Exclusion Criteria:

• Patients received antitumor treatment before

• 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	410013

Sponsors and Collaborators

• Hunan Province Tumor Hospital

Investigators

• Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yongchang Zhang, Professor, Hunan Province Tumor Hospital
• ClinicalTrials.gov Identifier: NCT04997382
• Other Study ID Numbers: ALICE
• First Posted: Aug 9, 2021
• Last Update Posted: Mar 24, 2022
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yongchang Zhang, Professor, Hunan Province Tumor Hospital: Non-small Cell Lung Cancer; Alectinib; ALK Rearranged
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Mar 24, 2022