Furmonertinib for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+210 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: ArriVent BioPharma, Inc.
Must not be taking: EGFR-targeting agents
Disqualifiers: Prior systemic therapy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing furmonertinib at two different doses to treat a specific type of lung cancer. It targets patients with advanced or metastatic non-squamous NSCLC who have a particular genetic mutation. The medication works by blocking a protein that helps cancer cells grow, potentially slowing down or stopping the cancer.
Do I need to stop my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you have not received any prior systemic anticancer therapy for advanced or metastatic NSCLC, including EGFR-targeting agents.
What evidence supports the effectiveness of the drug Furmonertinib for non-small cell lung cancer?
Cisplatin-based chemotherapy, which is part of the treatment plan, has been shown to improve survival and quality of life in patients with advanced non-small cell lung cancer. Additionally, combining new drugs with cisplatin has resulted in better outcomes than using cisplatin alone.
12345Is Furmonertinib safe for humans?
Furmonertinib has been studied for safety in patients with non-small cell lung cancer, and these studies generally support its safety in humans. It has been tested in various clinical trials, including those for advanced lung cancer, and continues to be evaluated for its safety profile.
678910What makes the drug Furmonertinib unique for treating non-small cell lung cancer?
Furmonertinib is unique because it is combined with platinum-based chemotherapy, which has been shown to improve survival and quality of life in advanced non-small cell lung cancer. This combination may offer a novel approach compared to traditional single-agent therapies, potentially enhancing treatment effectiveness.
35111213Eligibility Criteria
This trial is for adults with advanced non-squamous Non-Small Cell Lung Cancer (NSCLC) that can't be removed by surgery or cured with radiotherapy. They must have a specific mutation in their cancer cells called EGFR exon 20 insertion and should not have had previous systemic anticancer treatments for advanced NSCLC, including any drugs targeting EGFR.Inclusion Criteria
I haven't received any systemic anticancer treatments for my advanced NSCLC, including EGFR-targeting therapies.
I have had brain metastases treated or have new ones without symptoms.
My advanced lung cancer cannot be cured with surgery or radiation.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either furmonertinib at 160 mg or 240 mg once daily, or platinum-based chemotherapy
Until disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 30 days after last dose
Participant Groups
The study compares two doses of a new oral drug, furmonertinib (160 mg and 240 mg daily), against standard platinum-based chemotherapy in patients who haven't been treated before for their lung cancer. Participants will be randomly assigned to one of the three treatment groups.
3Treatment groups
Experimental Treatment
Active Control
Group I: furmonertinib 240 mgExperimental Treatment1 Intervention
furmonertinib tablet
Group II: furmonertinib 160 mgExperimental Treatment1 Intervention
furmonertinib tablet
Group III: platinum-based chemotherapyActive Control1 Intervention
carboplatin or cisplatin based on investigator's choice + pemetrexed intravenously
Furmonertinib is already approved in China for the following indications:
🇨🇳 Approved in China as Furmonertinib for:
- Non-Small Cell Lung Cancer (NSCLC) with EGFR mutations
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Arrivent Investigative SiteAbilene, TX
Arrivent Investigative SiteSioux Falls, SD
Arrivent Investigative SiteFlorham Park, NJ
ArriVent Investigative SiteCincinnati, OH
More Trial Locations
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Who Is Running the Clinical Trial?
ArriVent BioPharma, Inc.Lead Sponsor
Allist Pharmaceuticals, Inc.Industry Sponsor
References
Combination therapy versus single agent chemotherapy in non-small cell lung cancer. [2019]There is proven evidence of improved symptom control with platinum-based chemotherapy in the palliation of non-small cell lung cancer, and small but definite improvements in progression-free and overall survival when compared with best supportive care. The newer chemotherapy agents vinorelbine, gemcitabine, docetaxel and paclitaxel all have single agent activity, and in combination with cisplatin these provide superior quality of life and/or survival compared with the single agents, albeit with some increase in haematological toxicity. Doublet chemotherapy consisting of a new agent combined with platinum, cisplatin by preference where tolerated, has become the standard of care for advanced disease. The use of a functional assessment of fitness, rather than chronological age alone, is appropriate in the treatment of elderly patients. Although in this group there is evidence that doublets are superior to single agents, treatment should be undertaken with caution. In the second line setting where patients are unlikely to tolerate combination therapy, single agents have proven superiority over best supportive care. Patients with poor performance status (PS2) without comorbidity may tolerate combination therapy, but currently available evidence is insufficient to allow a definitive recommendation for combination or single-agent chemotherapy.
Paclitaxel, cisplatin, and gemcitabine combination chemotherapy within a multidisciplinary therapeutic approach in metastatic nonsmall cell lung carcinoma. [2022]Cisplatin-based chemotherapy combinations improve quality of life and survival in advanced nonsmall cell lung carcinoma (NSCLC). The emergence of new active drugs might translate into more effective regimens for the treatment of this disease.
New chemotherapeutic agents for the treatment of non-small cell lung cancer: the Japanese experience. [2019]Non-small cell lung cancer (NSCLC) is refractory to systemic chemotherapy, compared with small cell lung cancer. Until recently, only five drugs--cisplatin, vindesine, mitomycin, ifosfamide, and vinblastine--could produce overall response rates of 15% against NSCLC. However, recent efforts have contributed to the development of new drugs with activity against NSCLC, including irinotecan hydrochloride (CPT-11), paclitaxel, docetaxel, vinorelbine, and gemcitabine. Combination chemotherapy against NSCLC using these agents has demonstrated high response rates. In Japan, various combination chemotherapy and combined-modality regimens employing CPT-11 have been evaluated for their efficacy. Randomized controlled trials to establish new state-of-the-art treatments for NSCLC are ongoing.
New drugs in the palliative chemotherapy of advanced non-small-cell lung cancer. [2017]In inoperable advanced non-small-cell lung cancer (NSCLC), palliative chemotherapy is established and aims at palliation of symptoms, improvement of quality of life and prolongation of survival. In the last years, several new drugs with enhanced activity towards NSCLC and improved toxicity profile have been characterised, for example vinorelbine, gemcitabine, paclitaxel and docetaxel. Data from randomised trials suggest that regimens containing new drugs are more active than older combinations. Platin-based combinations of either vinorelbine, gemcitabine or paclitaxel have resulted in better outcome than cisplatin alone and new drugs in combination with platins are more active than the corresponding single agent. Non-platin-based combinations must be considered investigational until their non-inferiority to platin-based protocols has been proven in randomised trials on large patient populations. Patients with good performance status and adequate organ function should receive platin-based chemotherapy that includes the new drugs (vinorelbine, gemcitabine, paclitaxel or docetaxel). New drugs without platins are suitable for elderly patients and patients with poor performance status. Second-line chemotherapy prolongs survival in selected patients and should be particularly offered to patients with good performance status.
An update on European randomized studies in non-small cell lung cancer. [2007]Less than 25% of non-small cell lung cancer (NSCLC) patients present with surgically resectable stage I and II disease, and the majority of patients will eventually die of disseminated disease. Cisplatin-based chemotherapy has been shown to prolong survival and improve quality of life in patients with stage III and IV disease. In recent years, new chemotherapeutic agents (eg, gemcitabine, paclitaxel, docetaxel, vinorelbine, and irinotecan) have shown definite activity in advanced NSCLC. The activity of these agents has led to phase II studies combining them with cisplatin, producing response rates that are generally in excess of 35%. Randomized trials suggest that survival is improved when combinations of gemcitabine/cisplatin, vinorelbine/cisplatin, and paclitaxel/cisplatin are compared with cisplatin alone or cisplatin/etoposide. The following report reviews the ongoing trials in NSCLC.
Efficacy, safety, and genetic analysis of furmonertinib (AST2818) in patients with EGFR T790M mutated non-small-cell lung cancer: a phase 2b, multicentre, single-arm, open-label study. [2021]Furmonertinib (AST2818) is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) targeting both sensitising EGFR and EGFR Thr790Met (T790M) mutations. This study aimed to assess the efficacy and safety of furmonertinib in patients with EGFR T790M mutated advanced non-small-cell lung cancer (NSCLC).
Intracranial efficacy and safety of furmonertinib 160 mg with or without anti-angiogenic agent in advanced NSCLC patients with BM/LM as salvage therapy. [2023]Central nervous system (CNS) metastases including brain metastases (BM) and leptomeningeal metastases (LM) are frequent in epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), and are correlated with poor outcomes. In this study, we evaluated the efficacy of single-agent furmonertinib 160 mg or combining with anti-angiogenic agent in NSCLC patients who had developed BM/LM progression from previous tyrosine kinase inhibior (TKI) treatment.
Furmonertinib (AST2818) versus gefitinib as first-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer (FURLONG): a multicentre, double-blind, randomised phase 3 study. [2022]Furmonertinib (AST2818) is an irreversible, selective, third-generation EGFR tyrosine-kinase inhibitor. We aimed to investigate the efficacy and safety of furmonertinib versus the first-generation EGFR tyrosine-kinase inhibitor gefitinib as first-line treatment in patients with EGFR mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC).
A real-world study of the efficacy and safety of furmonertinib for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations. [2023]Furmonertinib is a novel third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). A phase Ib study (FAVOUR, NCT04858958) initially demonstrated the efficacy of furmonertinib in non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion (ex20ins). This study aimed to investigate the real-world efficacy and safety of furmonertinib in patients with advanced NSCLC with EGFR ex20ins.
Furmonertinib: First Approval. [2022]Furmonertinib mesylate (hereafter furmonertinib) [Ivesa®] is a selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being developed by Allist Pharmaceuticals for the treatment of patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). In March 2021, furmonertinib received its first approval in China for the treatment of patients with locally advanced or metastatic NSCLC with confirmed EGFR T790M mutation whose disease has progressed during or after EGFR TKI therapy. Furmonertinib (as monotherapy and/or combination therapy) continues to be assessed in phase I/II and phase III trials for NSCLC with EGFR mutation in China, and its clinical development is also underway/planned in China and elsewhere for NSCLC with various EGFR mutations. This article summarizes the milestones in the development of furmonertinib leading to this first approval for EGFR T790M-positive NSCLC.
Rationale for non-platinum chemotherapy in advanced NSCLC. [2022]During the past decade, five new cytotoxic drugs have been introduced that are active against non-small-cell lung cancer (NSCLC). These agents include vinorelbine (Navelbine), paclitaxel (Taxol), docetaxel (Taxotere), gemcitabine (Gemzar), and irinotecan (CPT-11, Camptosar). Used alone, these drugs display activity comparable to cisplatin. The combination of cisplatin and one of the newer drugs produces better survival than treatment with cisplatin (Platinol) alone. Randomized studies of chemotherapy regimens that include these newer drugs have demonstrated improved survival, fewer side effects, or both, compared with earlier standard combinations such as cisplatin/vindesine or cisplatin/etoposide. Docetaxel and perhaps some of the other newer drugs are of value for patients previously treated with platinum-containing regimens. Future studies should determine whether combinations of these newer drugs are superior to cisplatin-containing regimens. Although improved survival is the most important factor in defining the best regimen in non-small-cell lung cancer, additional considerations include patient tolerability, costs of administration, and the rationale for and ability to include noncytotoxic agents (such as inhibitors of signal transduction pathwriys or angiogenesis) into the therapeutic program.
[Stage IV NSCLC. Place of chemotherapy]. [2013]Cisplatin based chemotherapy for stage IV non small cell lung cancer patients with good performance status is associated with improved survival and better symptom control. Chemotherapeutic regimens should include cisplatin with at least one other active drugs as ifosfamide, mitomycin C, vindesine, vinblastine (second generation drugs) or gemcitabine, paclitaxel, docetaxel, irinotecan and/or vinorelbine (third generation drugs). If the other drug is a new one, there is no evidence for the addition of a third agent. Four to six cycles is proposed in responding patients. Non-platinum-based regimens may be used in cases where platinum-based chemotherapy is contra-indicated. Single agent chemotherapy may be considered in patients with poor performance status.
Gemcitabine and carboplatin treatment in advanced NSCLC: a retrospective evaluation including elderly patients. [2022]Carboplatin-containing regimens are sometimes preferred for patients with advanced non-small cell lung cancer.