Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)

NCT05724004 | Recruiting

• 1 other identifier: A-SAB
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn evaluate the safety and efficacy of the addition of radiation therapy to all tumour lesions, to first line medical treatment with alectinib in non-small cell lung cancer harbouring ALK-rearrangements. The main aims of the trial are to evaluate:

• if the treatment combination is safe
• if the treatment combination can inhibit progression Participants who have responded to 1st line alectinib will be treated with consolidation radiation therapy to all remaining tumour lesions while continuing on alectinib until disease progression, unacceptable toxicity or another discontinuation criterion is met.

Conditions

Radiotherapy Side Effect; Non-small Cell Lung Cancer; ALK Gene Mutation

Keywords

Stereotactic body radiation therapy; SBRT; Radiotherapy; Non-small Cell Lung Cancer; ALK-rearrangement

Outcome Measures

Primary Outcomes (2)

• Toxicity (safety)

  No and percentage of patients suffering grade 3-5 toxicity attributed to RT and within 6 months post RT).

  6 months post radiation therapy

• Progression free survival (PFS)

  PFS-rate at 12 months (KM-estimated method). Successrate is 12-month-PFS-rate of 85%. Median PFS will also be measured

  PFS rate at 12 months after initiation of alectinib

Secondary Outcomes (4)

• Overall survival

  5 years

• Progression free survival II

  5 years

• Time to treatment failure

  3 years

• Time to next therapy

  5 years

Other Outcomes (1)

• Translational biomarker studies

  5 years

Study Arms (1)

Radiotherapy + alectinib

EXPERIMENTAL

All patients receive consolidation radiation therapy to all active tumour lesions after induction treatment with alectinib.

Radiation: SBRT/SRS/radiation therapy

Interventions

SBRT/SRS/radiation therapy RADIATION

Consolidation radiation therapy (SBRT/SRS/moderately hypofractionated radiation therapy)

Radiotherapy + alectinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological confirmed NSCLC:
• Stage IV NSCLC OR
• Stage III NSCLC not suitable for surgery or radiochemotherapy OR
• Recurrent NSCLC after previous surgery (not amendable for curative multimodal therapy)
• ALK-rearrangement
• Adequate organ function to tolerate alectinib and clinical tolerance to alectinib
• Stable disease (SD) or partial response (PR) after 2-3 months induction treatment with alectinib
• Maximum 5 tumour lesions +/- thoracic lymph nodes active on an 18F-FDG-PET scan post induction treatment with alectinib
• All active tumour lesions amendable to RT under the following conditions:
• All metastases possible to treat with
• Extracranial metastases: SBRT of at least 7 Gy x 5 (corresponding to 50 Gy EQD2 using alfa/beta 10Gy)
• Intracranial metastases: SRS or f-SRS
• The primary tumour and/or lymph nodes and/or pulmonary metastases amendable to SBRT (≥ 7Gy x 5, see above) or moderately hypofractionated RT of 3 Gy x 15 (corresponding to 49 Gy EQD2 using alfa/beta 10Gy)
• Adequate organ function to tolerate SBRT/RT:
• Fulfilment of dose constraints to adequate organs at risk

You may not qualify if:

• Leptomeningeal carcinosis (on MRI or in cerebrospinal fluid (CSF))
• Persistent malignant pleural effusion, malignant pericardial effusion or malignant ascites after induction treatment
• PD after 2-3-month-induction treatment with alectinib
• Previous TKI, chemotherapy or immunotherapy (previous adjuvant chemotherapy for early stage NSCLC is allowed) for metastatic NSCLC
• Previous RT for NSCLC (any stage)
• Previous RT for any other cancer within the last 3 years possibly interfering with the planned RT within this study
• Life expectancy of less than 6 months
• Inability to understand given information or undergo study procedures according to protocol.
• Has evidence or a past medical history of interstitial lung disease or active, non-infectious pneumonitis or known pulmonary fibrosis.
• Pregnant or breast-feeding. Patients must agree to use safe contraception during and for 3 months after study treatment.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 171 76, Sweden

RECRUITING

MeSH Terms

Conditions

Radiation Injuries; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Wounds and Injuries; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Karin Lindberg, MD, PhD

  Karolinska University Hospital

  STUDY DIRECTOR

Central Study Contacts

Karin Lindberg, MD, PhD

CONTACT

+46851770000; karin.lindberg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Single arm, multicenter, phase I/II study

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 13, 2023
• Study Start: October 5, 2023
• Primary Completion: June 20, 2024
• Study Completion (Estimated): June 20, 2031
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)