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Report for Clinical Trial NCT04285671

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

UCLA L-08: A Phase Ib/II Study of Combined HER Inhibition Adding Necitumumab and Trastuzumab to Osimertinib in Patients With Refractory EGFR-Mutated Lung Cancer

This phase Ib/II trial studies the side effects and best dose of trastuzumab and necitumumab together with osimertinib, and to see how well they work for the treatment of stage IV non-small cell lung cancer that is EGFR-mutated, resistant to osimertinib, and has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as trastuzumab and necitumumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and necitumumab together with osimertinib may work better than osimertinib alone in treating patients with stage IV EGFR-mutated non-small cell lung cancer.

NCT04285671 Metastatic Lung Non-Small Cell Carcinoma Refractory Lung Non-Small Cell Carcinoma Stage IV Lung Cancer American Joint Committee on Cancer (AJCC) v8 Stage IVA Lung Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8
MeSH:Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Carcinoma Neoplasm of the lung Non-small cell lung carcinoma

5 Interventions

Name: Necitumumab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (necitumumab, trastuzumab, osimertinib)

Name: Osimertinib

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (necitumumab, trastuzumab, osimertinib)

Name: Quality-of-Life Assessment

Description: Ancillary studies
Type: Other
Group Labels: 1

Treatment (necitumumab, trastuzumab, osimertinib)

Name: Questionnaire Administration

Description: Ancillary studies
Type: Other
Group Labels: 1

Treatment (necitumumab, trastuzumab, osimertinib)

Name: Trastuzumab

Description: Given IV
Type: Biological
Group Labels: 1

Treatment (necitumumab, trastuzumab, osimertinib)


Primary Outcomes

Measure: Identification of the recommended phase II dose (R2PD) regimen for combination osimertinib, necitumumab, trastuzumab (ONT) therapy (Phase Ib)

Time: Up to 1 year

Description: Will be defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0).

Measure: Incidence of adverse events (Phase Ib)

Time: Up to 1 year

Description: Will be based on the Full Analysis Set (FAS) of the phase II portion of the trial and the phase Ib patients treated at the recommended phase II dose (RP2D). ORR is defined as defined as complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Will be determined by the investigator. A Cox proportional hazards model will be used to estimate the hazard ratio and its 95% confidence interval (CI).

Measure: Objective response rate (ORR) (Phase II)

Time: Up to 1 year

Secondary Outcomes

Description: PFS is defined as the time from trial initiation to cancer progression per RECIST 1.1 based on investigator assessment or death due to any cause.

Measure: Progression free survival (PFS) (Phase II)

Time: Up to 1 year

Description: DoR is time from documentation of tumor response to disease progression.

Measure: Duration of response (DoR) (Phase II)

Time: Up to 1 year

Description: OS is defined as time from randomization to death by any cause.

Measure: Overall survival (OS) (Phase II)

Time: Up to 1 year

Measure: Time to response (TTR)

Time: Up to 1 year

Description: Will be assessed using Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Measure: Patient reported outcomes (PROs)

Time: Up to 1 year

Other Outcomes

Description: Will be obtained from the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. Will be analyzed by the clinical biostatisticians in the University of California, Los Angeles (UCLA) Department of Medicine Medical Statistics Core.

Measure: Quality of life data questionnaire

Time: Up to 1 year

Description: Will be assessed using response from liquid biopsies and optional but recommended baseline tissue biopsy. Will correlate pre-and post-treatment biopsies molecular changes (i.e. expression of HER2, HER3, AXL, MET) with response.

Measure: Potential biomarkers associated with response from liquid biopsies

Time: Up to 1 year

Description: Will be assessed using liquid biopsy with response.

Measure: Mutant allele fraction in circulating tumor deoxyribonucleic acid (DNA) (ctDNA)

Time: Up to 1 year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

Enrollment of patients with mutations other than exon 19 deletion and the L858R point mutation require literature supporting sensitivity to EGFR tyrosine kinase inhibitors - Progressed on osimertinib. --- L858R ---



HPO Nodes


HPO: