A Study to See How Well and How Safely Different Treatments Work in a Group of Participants With Non-Small Cell Lung Cancer (NSCLC) (HORIZON 2)

Roche

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Pemetrexed; Drug: Alectinib; Drug: Cisplatin; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06624059

BO43249

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and/or safety of multiple therapies in patients with early-stage resectable NSCLC. Cohort B1 is a phase II cohort that will evaluate the safety, and efficacy of alectinib in combination with up to four cycles of platinum-based chemotherapy in the adjuvant setting post complete surgical resection. Cohort B2 is a phase II cohort that will evaluate the efficacy and safety of perioperative alectinib in combination with chemotherapy in the neoadjuvant setting.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Cohort B1:

• Complete resection of the primary NSCLC with negative margins
• Confirmed stage II to select stage IIIB (T3N2) NSCLC of non-squamous (adenocarcinoma) histology
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1

Inclusion Criteria Cohort B2:

• Evaluation by the operating attending surgeon and involved medical oncologist prior to study enrollment to verify study eligibility for complete surgical resection with curative intent
• Pathologically and/or histologically confirmed Stage II-IIIA and IIIB (T3N2 only) NSCLC of non-squamous (adenocarcinoma) histology

Inclusion Criteria Cohorts B1 and B2:

• Documented ALK fusion

Exclusion Criteria Cohort B1:

• NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
• Prior exposure to any systemic anti-cancer therapy

Exclusion Criteria Cohort B2:

• NSCLC of squamous or mixed histology regardless of the presence of an ALK mutation
• Known sensitivity to any component of alectinib, pemetrexed, cisplatin, or carboplatin
• Prior exposure to any systemic anti-cancer therapy

Exclusion Criteria Cohorts B1 and B2:

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Cohort B1

Experimental group

Description:

Participants will receive alectinib in combination with platinum-based chemotherapy for up to 4 cycles (cycle length = 3 weeks), followed by alectinib monotherapy for up to 5 years.

Treatment:

Drug: Carboplatin

Drug: Cisplatin

Drug: Alectinib

Drug: Pemetrexed

Cohort B2

Experimental group

Description:

Participants will receive alectinib and platinum-based chemotherapy for up to 3 cycles (cycle length = 3 weeks) prior to surgery, and alectinib monotherapy after surgery for up to 5 years after surgery.

Treatment:

Drug: Carboplatin

Drug: Cisplatin

Drug: Alectinib

Drug: Pemetrexed