SHERLOC: A Phase 2 Study of MM-121 in Combination With Docetaxel Versus Docetaxel Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Brief SummaryThe 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.
Detailed DescriptionThis 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.
PhasePhase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion 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
- 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
Please contact Poornima Murali to learn more about where you can participate in this trial. Please use the contact form on the right side.