A number of new studies in lung cancer have started in recent months. Could one of your patients benefit from participating?
EGFR-positive stage 1A2–1A3 non–small cell lung cancer (NSCLC) after tumor resection. Adult patients in this clinical scenario can join a phase 3 study testing the effectiveness of osimertinib (Tagrisso). This third-generation oral kinase inhibitor has already been approved for adjuvant treatment on the basis of data from patients with EGFR+ stage 1B tumors or worse; this trial will assess its benefit in earlier disease. Participants will be assigned to receive either daily tablets of osimertinib or placebo until disease recurrence, unacceptable toxicity, or other reasons for discontinuation for up to 3 years. Disease-free survival (DFS) is the primary endpoint. Overall survival (OS) is a secondary endpoint, and quality of life (QoL) will not be assessed. Trial centers worldwide started recruiting 380 participants in February; sites in 12 US states are planned. More details at clinicaltrials.gov
Stage 1B, 2, or 3A NSCLC after surgery or radiotherapy. People with early-stage lung cancer whose tumor features a RET gene fusion are being recruited for a randomized, phase 3 study assessing whether oral selpercatinib (Retevmo) can prevent recurrence. This kinase inhibitor is already approved for use in metastatic disease with RET+ tumors, but this was an accelerated approval, and trials confirming clinical efficacy in that setting are still awaited. This trial is investigating use of the drug in earlier-stage disease that has not yet spread. Patients will take twice-daily capsules of selpercatinib or placebo for up to 3 years until an “event” such as disease progression/recurrence or death occurs. Event-free survival is the primary outcome. OS is a secondary outcome, and QoL apart from physical function will not be tracked. The study opened in 31 countries and in California, Florida, Massachusetts, New York, and Tennessee in December. The researchers hope to enroll 170 participants. More details at clinicaltrials.gov
Extensive-stage small-cell lung cancer requiring first-line therapy. Adults with this type of lung cancer are sought for a phase 3 trial assessing whether survival can be prolonged by an experimental co-formulation of the immunotherapies pembrolizumab and vibostolimab, called MK-7684A. The new combo will be compared to the current standard treatment, which includes a mix of atezolizumab (Tecentriq), platinum, and etoposide. Patients in the MK-7684A group will receive three weekly infusions of MK-7684A plus etoposide and platinum for 12 weeks then continue with MK-7684A alone. The control group will receive standard infusions of the atezolizumab mix every 3 weeks for 12 weeks, then atezolizumab alone. All patients will continue on treatment until their disease progresses or the treatment becomes intolerable. The study opened in March in Israel and Korea and at the Hattiesburg Clinic, in Mississippi. It aims to enroll 450 participants. OS over approximately 3 years is the primary outcome; QoL is a secondary outcome. More details at clinicaltrials.gov
Stage 3 unresectable NSCLC that has not progressed following concurrent chemoradiotherapy. Adult patients in this situation with documented EGFR, ALK wild-type, and PD-L1 status can join a phase 3 study testing the PD-L1 blocker durvalumab (Imfinzi) in combination with one of two experimental drugs, oleclumab or monalizumab. Durvalumab is already indicated for such patients; this is one of several studies attempting to enhance its effectiveness by adding another targeted therapy. One group of participants will receive monthly infusions of durvalumab plus oleclumab, with an extra dose of oleclumab in each of the first 2 months. A second group will receive infusions of durvalumab plus monalizumab each month. The third group of patients will receive monthly durvalumab alone. All participants will be treated for up to 1 year. The trial began recruiting 999 participants in Michigan and Taiwan in February; additional sites in 16 US states and 15 other countries are gearing up. The primary outcome is progression-free survival (PFS). OS is a secondary outcome, and QoL will not be assessed. More details at clinicaltrials.gov
Advanced or metastatic PD-L1–negative NSCLC. People with these types of lung cancer are eligible for a National Cancer Institute phase 2/3 study to see whether survival can be prolonged by adding stereotactic body radiotherapy (SBRT) to usual treatment of immunotherapy with or without chemotherapy. Participants in the control group will receive one of six combinations of immunotherapy and chemotherapy infusions approximately every 3–6 weeks for 2 years. Patients in the SBRT arm will receive, in addition to the infusions, three fractions of radiation every other day. The study started in December and aims to recruit 100 participants across Delaware, Illinois, Iowa, and Pennsylvania. OS and PFS are primary endpoints, and QoL will be tracked. More details at clinicaltrials.gov
Advanced or metastatic PD-L1–high NSCLC without actionable genomic variations. Patients with this type of lung cancer who have not yet received systemic therapy for advanced/metastatic disease are being sought for a phase 3 trial testing datopotamab deruxtecan (Dato-DXd) in combination with standard pembrolizumab (Keytruda). Dato-DXd is an experimental antibody-drug conjugate that targets trophoblast cell-surface antigen 2 (Trop2), which is overexpressed in many cancers, including NSCLC, and is associated with poor survival. Earlier studies of Dato-DXd in advanced or metastatic NSCLC included previously treated patients; this trial tests the performance of Dato-DXd in the first line. For up to approximately 32 months, participants will receive three weekly infusions of either pembrolizumab alone or pembrolizumab plus Dato-DXd. OS and PFS are primary endpoints; QoL will not be assessed. Study sites in California and Japan started recruiting 740 participants in March. More details at clinicaltrials.gov
All trial information is from the National Institutes of Health US National Library of Medicine (online at clinicaltrials.gov).
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