A Study in Non-Small Cell Lung Cancer

N-Power Medicine

Status: Enrolling

Conditions: Non Small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT07174388

NPM-004

Details and patient eligibility

About

A study to create control arms using current and future information in patients with lung cancer that has spread who have already received chemotherapy.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. > 18 years of age at the time of informed consent 2. Pathologically confirmed NSCLC 3 .ECOG Performance of >1 and fit for further systemic therapy on a NCCN approved regimen (within 4 weeks prior or 14 days after starting second line therapy) 4. Life expectancy of more than 3 months 5. Able to understand and sign informed consent *see protocol for cohort specific inclusion criteria*

Exclusion criteria

1. Unable to provide informed consent
2. Actively on a clinical trial of an investigational agent
3. Non protocol compliant baseline imaging scan (modality/coverage) prior to index date in patients included after the second or third line therapy has been initiated *see protocol for cohort specific exclusion criteria* -

Trial design

550 participants in 9 patient groups

Cohort 1

Description:

Patients starting first line pembrolizumab or pembrolizumab in combination with a platinum doublet

Cohort 2

Description:

Patients with KRASG12D mutation starting first or later line of therapy

Cohort 3

Description:

Patients planned to have second line docetaxel or docetaxel in combination with ramucirumab with tumor without alterations in KRAS, EGFR, ALK, or ROS1

Cohort 4

Description:

Patients with PD-L1 \> 50% treated with single agent immuno-oncology therapy (IO) or dual IO agents as first line treatment.

Cohort 5

Description:

Patients with PD-L1 \< 50% without alterations in KRAS, EGFR, ALK, or ROS1

Cohort 6

Description:

Patients with documented KRAS G12C mutation

Cohort 7

Description:

Patients with non-G12C and non-G12D KRAS mutations

Cohort 8

Description:

Patients with EGFR mutations with prior treatment with osimertinib in combination with chemotherapy or lazertinib in combination with amivantamab

Cohort 9

Description:

Patients initiating single agent docetaxel or docetaxel and ramucirumab as third line of therapy