BAY2927088 for Non-Small Cell Lung Cancer
(SOHO-02 Trial)
Recruiting in Palo Alto (17 mi)
+329 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Bayer
Must be taking: Platinum-based chemotherapy
Must not be taking: Chronic systemic corticosteroids
Disqualifiers: Prior malignancy, Peripheral neuropathy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations.
Advanced NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body or that are unlikely to be cured or controlled with currently available treatments. HER2 is a protein that helps cells to grow and divide. A damage (also called mutation) to the building plans (genes) for this protein in cancer cells leads to a production of abnormal HER2 and therefore abnormal cell growth and division.
The study treatment, BAY 2927088, is expected to block the mutated HER2 protein which may stop the spread of NSCLC.
The main purpose of this study is to learn how well BAY 2927088 works and how safe it is compared with standard treatment, in participants who have advanced NSCLC with specific genetic changes called HER2 mutations.
The study participants will receive one of the study treatments:
* BAY 2927088 twice every day as a tablet by mouth, or
* Standard treatment in cycles of 21 days via infusion ("drip") into the vein. The treatment will continue for as long as participants benefit from it without any severe side effects or until they or their doctor decide to stop the treatment.
During the study, the doctors and their study team will:
* take imaging scans, including CT, PET, MRI, and X-rays, of different parts of the body to study the spread of cancer
* check the overall health of the participants by performing tests such as blood and urine tests, and checking
* heart health using an electrocardiogram (ECG)
* perform pregnancy tests for women
* ask the participants questions about how they are feeling and what adverse events they are having.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are unable to stop chronic systemic corticosteroids. Other medications may be allowed, but it's best to discuss your specific situation with the study team.
What data supports the effectiveness of the drug BAY 2927088 for non-small cell lung cancer?
The research suggests that early phase trials of targeted therapies in lung cancer, like BAY 2927088, often show promising results that are consistent with later, larger trials. This indicates that early positive outcomes might reliably predict effectiveness in broader use.
12345What makes the drug BAY2927088 unique for treating non-small cell lung cancer?
BAY2927088 is unique because it targets specific genetic mutations in non-small cell lung cancer, potentially offering a tailored treatment option for patients with these mutations, unlike standard treatments that may not address these specific genetic factors.
678910Eligibility Criteria
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has spread and has specific HER2 gene mutations. Participants must be able to take oral medication and undergo regular health checks, imaging scans, and possibly pregnancy tests.Inclusion Criteria
I haven't had systemic therapy for advanced cancer or specific HER2 treatments.
My cancer has a specific HER2 mutation confirmed by a certified lab test.
I am at least 18 years old or the legal age of consent in my country.
+2 more
Exclusion Criteria
I cannot stop taking my long-term steroids but don't use them heavily for asthma or local injections.
I have moderate to severe nerve damage in my hands or feet.
My tumor has a genetic change treatable with approved drugs, except for HER2 changes in the TKD.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive BAY 2927088 twice daily as a tablet by mouth or standard treatment in 21-day cycles via infusion until disease progression or unacceptable toxicity
Up to approximately 2 years
Regular visits for imaging scans and health assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to approximately 4 years
Participant Groups
The effectiveness and safety of BAY 2927088, a tablet taken twice daily aimed at blocking mutated HER2 proteins in NSCLC patients, are being compared with standard chemotherapy treatments administered via infusion every 21 days.
2Treatment groups
Experimental Treatment
Active Control
Group I: BAY2927088Experimental Treatment1 Intervention
Participants will receive BAY2927088 20 mg BID until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.
Group II: Standard of care (SoC)Active Control4 Interventions
Participants will receive SoC (pembrolizumab in combination with platinum-based chemotherapy, in 21-day cycles per the approved labels) until disease progression per RECIST v1.1, unacceptable toxicity, or until any other withdrawal criteria.
BAY 2927088 is already approved in United States for the following indications:
🇺🇸 Approved in United States as BAY 2927088 for:
- Non-small cell lung cancer (NSCLC) with HER2 mutations
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Michigan Hematology & Oncology ConsultantsFarmington Hills, MI
The U Chicago Medicine Comprehensive Cancer CenterChicago, IL
Providence Cancer Institute - Franz ClinicPortland, OR
Jewish General Hospital - Department of Pulmonary OncologyMontreal, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
BayerLead Sponsor
References
Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer. [2021]This dose-finding study evaluated lenvatinib, an oral multitargeted receptor tyrosine kinase inhibitor, in combination with carboplatin/paclitaxel in chemotherapy-naïve non-small-cell lung cancer (NSCLC) patients.
Efficacy of targeted therapies for oncogene-driven lung cancer in early single-arm versus late phase randomized clinical trials: A comparative analysis. [2022]There is an expanding number of approved targeted therapies for oncogene-driven lung cancer and many emerging therapies with promising efficacy data. Regulatory approvals are increasingly based on early phase trials (often single-arm phase II trials), in which the primary endpoint is objective response rate (ORR) or progression-free survival (PFS). Efficacy outcomes from early phase trials may not always correlate with those observed in later-phase randomized trials. In the precision oncology era with effective targeted therapies however, there are arguments for greater confidence in the efficacy outcomes from non-randomized single-arm trials. Nevertheless, there remain numerous challenges in understanding and interpreting efficacy outcomes for novel targeted therapies in trials that may have dose finding and safety as the primary objective and lack a standard-of-care control arm. Therefore, we sought to review the efficacy outcomes in early versus late phase clinical trials for approved targeted therapies in lung cancer - to better understand the interpretation of preliminary measures of clinical benefit. Nine pairs of early and late phase trials were identified, according to line of therapy for six targeted therapies in lung cancer (afatinib, ceritinib, crizotinib, dacomitinib, lorlatinib and osimertinib). Key efficacy outcomes, including ORR, PFS and overall survival (OS) were compared. Importantly, we found that in oncogene-driven lung cancer, early phase trial outcomes have historically been consistent with subsequent late phase trials. This suggests efficacy outcomes from early phase trials of targeted therapies in lung cancer may translate reliably to larger randomized trials. This has many potential implications for drug development in lung cancer, with regards to regulatory approvals and the design and conduct of clinical trials.
Assessing Toripalimab in NSCLC. [2022]According to CHOICE-01, a phase III trial in China, the PD-1 inhibitor toripalimab plus chemotherapy improves progression-free survival in patients with untreated non-small cell lung cancer lacking actionable mutations. The findings boost combination chemo-immunotherapy, rather than chemotherapy alone, as the new standard for this population.
Computed tomography-guided core-needle biopsy specimens demonstrate epidermal growth factor receptor mutations in patients with non-small-cell lung cancer. [2018]Target therapy with a new class of epidermal growth factor receptor (EGFR) inhibitors shows improved clinical response in EGFR gene-mutated lung cancers.
Activation of the Met kinase confers acquired drug resistance in FGFR-targeted lung cancer therapy. [2020]Aberrant fibroblast growth factor receptor (FGFR) activation/expression is a common feature in lung cancer (LC). In this study, we evaluated the antitumor activity of and the mechanisms underlying acquired resistance to two potent selective FGFR inhibitors, AZD4547 and BAY116387, in LC cell lines. The antitumor activity of AZD4547 and BAY1163877 was screened in 24 LC cell lines, including 5 with FGFR1 amplification. Two cell lines containing FGFR1 amplifications, H1581 and DMS114, were sensitive to FGFR inhibitors (IC50
How far we have come targeting BRAF-mutant non-small cell lung cancer (NSCLC). [2022]The advent of high-throughput sequencing has allowed to profoundly interrogate the molecular landscape of non-small cell lung cancer (NSCLC) in the last years. These findings constitute the opportunity to better stratify these patients in order to address specific treatments to well-defined oncogene-restricted subgroups. Among them, BRAF-mutated lung cancers represent around 4% of NSCLC, thus identifying a clinically relevant population that should be aptly managed. Pivotal phase II trials have demonstrated the efficacy of combinatorial treatment - dabrafenib plus trametinib, targeting both BRAF and MEK - for patients harboring V600E mutations, making this specific BRAF alteration a mandatory requirement in the genetic portrait of advanced non-squamous lung cancer patients. However, around half of BRAF+ NSCLC patients remain orphan of targeted approaches. Here we review the available evidence, mainly from a clinical perspective, of therapeutic strategies for both V600E and non-V600 patients, in terms of small molecule, immune checkpoint inhibitors and forthcoming integrated strategies. Looking at on-going clinical trials, a special attention is dedicated to emergent molecules and combinatorial strategies that not only will improve outcomes of classical V600E, but also will make concrete the chance of tailored treatments for the majority of BRAF-mutated patients.
Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. [2022]In the global FLAURA study, first-line osimertinib, a third-generation irreversible tyrosine kinase inhibitor (TKI) of epidermal growth factor receptor (EGFR), significantly improved progression-free survival (PFS) and overall survival (OS) versus comparator EGFR TKIs in patients with EGFR mutation-positive (EGFRm) advanced non-small-cell lung cancer (NSCLC).
Second-line Treatment of Advanced Non-small Cell Lung Cancer Non-oncogene Addicted: New Treatment Algorithm in the Era of Novel Immunotherapy. [2021]Most patients with advanced non-small cell lung cancer (NSCLC) have a poor prognosis and receive limited benefit from conventional treatments, especially in later lines of therapy. In recent years, several novel therapies have been approved for second- and third-line treatment of advanced NSCLC beyond old chemotherapy agents (docetaxel and pemetrexed) and the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI, erlotinib). In particular, the new antiangiogenetics (nindetanib and ramucirumab) in combination with docetaxel and immunotherapy (nivolumab, pembrolizumab and atezolizumab) have been recently approved and represent new treatment options.
Scientific Advances in Lung Cancer 2015. [2022]Lung cancer continues to be a major global health problem; the disease is diagnosed in more than 1.6 million new patients each year. However, significant progress is underway in both the prevention and treatment of lung cancer. Lung cancer therapy has now emerged as a "role model" for precision cancer medicine, with several important therapeutic breakthroughs occurring during 2015. These advances have occurred primarily in the immunotherapy field and in treatments directed against tumors harboring specific oncogenic drivers. Our knowledge about molecular mechanisms for oncogene-driven tumors and about resistance to targeted therapies has increased quickly over the past year. As a result, several regulatory approvals of new agents that significantly improve survival and quality of life for patients with lung cancer who have advanced disease have occurred. The International Association for the Study of Lung Cancer has gathered experts in different areas of lung cancer research and management to summarize the most significant scientific advancements related to prevention and therapy of lung cancer during the past year.
Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. [2023]The LUX-Lung 3 study investigated the efficacy of chemotherapy compared with afatinib, a selective, orally bioavailable ErbB family blocker that irreversibly blocks signaling from epidermal growth factor receptor (EGFR/ErbB1), human epidermal growth factor receptor 2 (HER2/ErbB2), and ErbB4 and has wide-spectrum preclinical activity against EGFR mutations. A phase II study of afatinib in EGFR mutation-positive lung adenocarcinoma demonstrated high response rates and progression-free survival (PFS).