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

Elevation Oncology

Status and phase: Terminated; Phase 2

Conditions: Adenocarcinoma; Heregulin; NSCLC; Non-Small Cell Lung Cancer

Treatments: Drug: Docetaxel; Drug: MM-121

Study type: Interventional

Funder types: Industry

Identifiers

NCT02387216

MM-121-01-02-09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Arm A: Experimental Arm

Experimental group

Description:

MM-121 in combination with Docetaxel

Treatment:

Drug: MM-121

Drug: Docetaxel

Arm B: Comparator Arm

Active Comparator group

Description:

Docetaxel alone

Treatment:

Drug: Docetaxel