A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC

Phase 2TerminatedNCT02387216

Elevation Oncology153 enrolled

Overview

The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.

This study is a randomized, open-label, international, multi-center, phase 2 study in patients with Heregulin-positive NSCLC histologically classified as adenocarcinoma that have progressed following no more than two systemic therapies for locally advanced or metastatic disease, one of which must have been a platinum containing regimen. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with docetaxel versus docetaxel alone.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

153

Conditions

Non-Small Cell Lung Cancer NSCLC Adenocarcinoma Heregulin

Interventions

MM-121DRUG

Investigational, fully human antibody targeting and inhibiting ErbB3

DocetaxelDRUG

approved chemotherapy treatment for NSCLC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a diagnosis of cytologically or histologically documented adenocarcinoma of the lung with either metastatic disease (stage IV), Stage IIIB or Stage IIIC disease not amenable to surgery with curative intent * Not received more than 2 prior systemic therapies- one of which must have been a platinum based regimen- for primary or recurrent disease * Tissue submitted for HRG-biomarker testing * ECOG performance status (PS) of 0 or 1 Exclusion Criteria: * Known ALK mutation * Presence of exon 19 deletion or exon 21 (L858R) substitution of the EGFR gene * Received \>2 prior systemic anti-cancer drug regimen for locally advanced disease * Prior treatment with an anti-ErbB3 antibody * CTCAE grade 3 or higher peripheral neuropathy * Symptomatic CNS metastases or CNS metastases requiring steroids * Any other active malignancy requiring systemic therapy * Clinically significant cardiac disease

Locations (35)

Unnamed facility

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Progression Free Survival

Progression Free Survival is defined as the time from randomization to the first documented radiographical progression of disease using RECIST v.1.1, or death from any cause, whichever came first based on investigator assessment. Patients that do not experience progression or death at the time of analysis were to be progression censored at the date of last valid tumor assessment. Progression-free survival time distribution and median survival for each treatment group were analyzed using the Kaplan-Meier method. Tumor response was evaluated by the local radiologist according to RECIST version 1.1 to establish disease progression by CT or MRI.

Time frame: Randomization until progression of disease or death due to any cause within 3 years,11 months (the study terminated prematurely)

Secondary Outcomes

Overall Survival

Overall Survival (OS) is defined as the time from the date of randomization to the date of death from any cause

Time frame: From date of randomization until the date of death from any cause assessed upto 3 years,11 months (the study terminated prematurely)

Objective Response Rate

Objective Response Rate (ORR) is defined as the proportion of patients a best overall response characterised as either a Complete Response (CR) or Partial Response (PR), as defined according to RECIST v1.1 guidelines, relative to the total number of evaluable patients. Complete Response (CR) is defined as disappearance of all lesions and pathologic lymph nodes. Partial Response (PR) is defined as \>=30% decrease in the sum of the longest diameter of target lesions

Time frame: Randomization through end of study up to 3 years, 11 months (the study terminated prematurely)

Time to Progression

Time to Progression (TTP) is defined as the time from the date of randomization to the date of objective tumor progression. In the actual analysis, duration of response (DOR) was analysed.

Time frame: Randomization to date of objective tumor progression up to 3 years, 11 months (the study terminated prematurely)

Data from ClinicalTrials.gov

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