Research & Trial Information
Protocol#: NRG – LU003
Cancer Type: Non-Squamous Non-Small Cell Lung Cancer
- Patients must have histologically or cytologically confirmed stage IV ALK-positive non-squamous NSCLC (includes M1a, M1b, M1c stage disease) ALK rearrangement must have been demonstrated by an FDA approved assay (Vysis FISH or Ventana IHC) or by next generation sequencing (NGS).
- Patient must be willing and able to undergo a fresh biopsy or if patient has a biopsy after progression on current TKI (and has continued TKI for clinical benefit per treating physician) this tissue may be used. Must have sufficient tissue.
- Age ≥ 18.
- Patient must have progressive disease.
- Patients who have received a cycle of chemotherapy at the time of original diagnosis of metastatic NSCLC are eligible as long as they have received a next generation ALK inhibitor.
- Patients with asymptomatic treated or untreated brain metastases are eligible. Treated brain metastases are eligible as long as patients have measurable disease outside the brain. Patients must be on a stable or decreasing dose of steroids for at least 7 days prior to step 2 registration. Anticonvulsants are allowed as long as the patient is neurologically stable and not deteriorating.
- Patients enrolled with asymptomatic brain mets must have at least one measurable target extracranial lesion.
- ECOG performance status 0-2.
- No major surgery within 2 weeks of study entry.Minor surgical procedures (eg, port insertion, pleurex catheter placement) are allowed and all wounds must not show signs of infection or draining.
- No radiation therapy (except palliative RT to relieve bone pain) within 2 weeks of study entry. Palliative RT (<10 fractions) must have been completed at least 48 hours prior to study entry. Stereotactic or small field brain irradiation must have completed at least 1 week prior to study entry. Whole brain RT must have completed at least 2 weeks prior to study entry.
- No prior dose of next generation ALK inhibitor (LDK378 (ceritinib), alectinib, ensartinib, lorlatinib] within 5 days prior to step 2 registration. Prior dose of brigatinib within 7 days prior to step 2 registration.
- Patients must not plan to receive any other investigational agents during the course of therapy.
- Patients with active malignancy other than ALK-positive non-squamous NSCLC within the last 2 years are excluded (note: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid cancer treated with curative intent, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for 2 years are eligible).
- No chemotherapy and/or immunotherapy allowed after step 1 registration.