Combining Alectinib with Radiation Therapy for Advanced Lung Cancer with ALK Mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of adding radiation therapy to alectinib treatment in patients with advanced non-small cell lung cancer (NSCLC) that has ALK-rearrangements. Participants who have shown a stable disease or partial response after 2-3 months of alectinib will receive stereotactic body radiation therapy (SBRT) to all remaining tumor lesions while continuing alectinib. The study aims to assess both the feasibility of this combination treatment and its impact on progression-free survival. The trial is designed for patients who are not candidates for surgery or traditional radiochemotherapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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)
2. ALK-rearrangement
3. Adequate organ function to tolerate alectinib and clinical tolerance to alectinib
4. Stable disease (SD) or partial response (PR) after 2-3 months induction treatment with alectinib
5. Maximum 5 tumour lesions +/- thoracic lymph nodes active on an 18F-FDG-PET scan post induction treatment with alectinib
6. 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)
7. Adequate organ function to tolerate SBRT/RT:

   * Fulfilment of dose constraints to adequate organs at risk
8. ECOG performance status (PS) 0-2
9. FEV1 ≥1 litre (only applicable for lung targets)
10. Age ≥ 20 years
11. Measurable lesions according to RECIST v 1.1
12. Signed written informed consent

Exclusion Criteria:

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

Where it's running

• Karolinska University Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Study coordinator: Karin Lindberg, MD, PhD
• Email: karin.lindberg@ki.se
• Phone: +46851770000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.