Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Lymphoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lymphosarcoma

Lorlatinib is administered orally at the daily dose of 100 mg (four tablets of 25 mg).

Lorlatinib will be taken continuously on a daily basis until disease progression, unacceptable toxicity, occurrence of any withdrawal criterion, whichever comes first.

Lorlatinib is administered orally at the daily dose of 100 mg (four tablets of 25 mg).

Lorlatinib

Anne-Marie Dingemans, MD

Laura Mezquita, MD

This study includes patients diagnosed with a metastatic non small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) translocation. The standard treatment for patients with metastatic non small cell lung cancer with ALK translocation is represented by personalized treatment with drugs called ALK inhibitors. During the treatment with an ALK inhibitor, the tumour can start to grow again, because the tumour adapts to the drug and develops escape mechanisms, becoming resistant. At the tumour cells level, the mechanisms underlying resistance can include the development of other alterations, mainly mutations, including in the ALK gene. The alterations that developed depend on the drug the tumour has been exposed to.

The alterations can be identified by analysing tumour tissue obtained through a biopsy, however, repeating a tumour biopsy is difficult and risky and might not be able to provide sufficient tissue for the test. Therefore in the last years, new tests have been developed to identify the mutations in the blood.

Lorlatinib is a drug that inhibits ALK and has already been identified to be able to control the tumour growth when ALK mutations are identified and is already approved as standard treatment after progression to a previous treatment with ALK inhibitors.

The purpose of this study is to identify which patient populations may benefit most from treatment with lorlatinib, based on the alterations found in their genes.

Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients

Activity of Lorlatinib Based on ALK Resistance Mutations on Blood in ALK Positive NSCLC Patients Previously Treated With 2nd Generation ALK Inhibitor

Progression Free Survival Rate at 12 months (PFSR-12) is defined as the proportion of patients at 12 months who are alive and non-progressing.

OS is defined as the time interval between the date of enrolment and the date of death from any cause. If no event has been observed, then the patient is censored at the last date known to be alive.

Overall Response Rate (ORR) is an overall rate including patients with documented complete response (CR) or partial response (PR)

Duration of Response will only be reported for patients who achieved either CR or PR. The duration of response is measured from the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. If progression has not been observed, the patient will be censored at the date of the last follow up examination. In the event of death without progression competing risk method will be used.

CNS Overall Response Rate (CNS ORR) is an overall rate including patients with documented complete response (CNS-CR) or partial response (CNS-PR)

Safety profile according to NCI CTCAE v.5

Spots Global Cancer Trial Database for anaplastic lymphoma kinase (alk) positive non small cell lung cancer (nsclc)