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CompletedLast updated: 21 December 2023

SHERLOC: This phase II trial is trying to determine whether adding a drug (MM-121) to treatment with Docetaxel or Pemetrexed is more effective than using either drug, alone, in patients with heregulin-positive Non-Small Cell (NSC) Lung CancerA Phase 2 Study of MM-121 in Combination With Docetaxel or Pemetrexed Versus Docetaxel or Pemetrexed Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical summary

Summary

This study is a randomized, open-label, international, multi-center, phase 2 study in patients with Heregulin-positive NSCLC that have progressed following no more than three systemic therapies for locally advanced or metastatic disease, of which one must have been a platinum based doublet therapy. All patients will initially be screened for heregulin status. Eligible patients will be randomized to receive MM-121 in combination with investigator's choice of either docetaxel or pemetrexed versus docetaxel or pemetrexed alone.

Conditions

This trial is treating patients with Non-Small Cell (NSC) Lung Cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

SHERLOC

More information

Trial Identifiers

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Trial sponsor

Merrimack Pharmaceuticals

Scientific Title

A Phase 2 Study of MM-121 in Combination With Docetaxel or Pemetrexed Versus Docetaxel or Pemetrexed Alone in Patients With Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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