Targeted Treatment for ALK Positive Patients Previously Treated for Non-squamous Non-small Cell Lung Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03737994

Provider View

This study is testing different combinations of drugs to see how well they work in treating patients with stage IV ALK positive non-squamous non-small cell lung cancer. The trial aims to find out if using ALK inhibitors or chemotherapy is more effective in stopping cancer growth.

Patient Parameters

Program Overview

This clinical trial is exploring how well a combination of ALK inhibitors and chemotherapy drugs work in treating patients with advanced ALK positive non-squamous non-small cell lung cancer. ALK inhibitors like lorlatinib, ceritinib, alectinib, brigatinib, ensartinib, and crizotinib may help stop cancer cells from growing by blocking certain enzymes. Chemotherapy drugs such as pemetrexed, cisplatin, and carboplatin work by killing cancer cells or stopping them from dividing and spreading. The study aims to determine which treatment approach is more effective for patients with this type of lung cancer.

Description

The main goals of this study are to see if certain genetic changes in cancer cells affect how well patients respond to ALK inhibitor therapy and to compare the effectiveness of ALK inhibitors with chemotherapy in patients without specific ALK mutations. The study will also look at how long patients live without the cancer getting worse, how long the treatment works, and overall survival rates. Additionally, the study will assess the safety of the treatments and how well they are tolerated by patients.

Patients with specific ALK mutations will receive different ALK inhibitors based on their mutation type. For example, those with a G1202R mutation may receive lorlatinib or brigatinib, while those with a C1156Y mutation may receive lorlatinib, brigatinib, or alectinib. Patients without ALK-resistant mutations may receive an ALK inhibitor or chemotherapy with pemetrexed and either cisplatin or carboplatin. Treatment cycles repeat every 21 days unless the cancer progresses or side effects become unacceptable.

After completing the study treatment, patients will be monitored regularly for up to five years to track their health and any changes in their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must have stage IV ALK-positive non-squamous non-small cell lung cancer confirmed by specific tests.
  • Must be willing to undergo a new biopsy or have a recent biopsy available.
  • Must have cancer that has progressed after one second-generation ALK inhibitor treatment.
  • Must not have received more than one second-generation ALK inhibitor or prior lorlatinib.
  • Must not have had chemotherapy except for one cycle at the time of initial diagnosis.
  • Must provide informed consent to participate.
  • Must meet specific blood count and organ function requirements.
  • Must be able to take oral medications.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.

Exclusion Criteria

  • Major surgery within two weeks before starting the study.
  • Recent radiation therapy must be completed within specific timeframes before starting the study.
  • Recent use of certain ALK inhibitors before starting the study.
  • History of certain lung diseases or gastrointestinal conditions that affect medication absorption.
  • Significant heart problems or infections.
  • Active pancreatitis or other serious illnesses.
  • Planning to receive other investigational treatments during the study.
  • Active cancer other than ALK-positive non-squamous NSCLC within the last two years, except for certain treated cancers.
  • No chemotherapy or immunotherapy allowed after initial registration.

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