Fianlimab + Cemiplimab + Chemotherapy for Non-Small Cell Lung Cancer
Recruiting in Palo Alto (17 mi)
+96 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Regeneron Pharmaceuticals
Must not be taking: Corticosteroids, Immunosuppressants
Disqualifiers: Brain metastases, EGFR mutations, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called fianlimab with cemiplimab and chemotherapy in patients with advanced lung cancer. The goal is to see if this combination is more effective than current treatments. The new drugs help the immune system fight cancer, while chemotherapy attacks the cancer cells directly.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on corticosteroid therapy or have received certain systemic therapies recently, you may need to adjust or stop those before joining the trial. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Fianlimab + Cemiplimab + Chemotherapy for Non-Small Cell Lung Cancer?
Research shows that cemiplimab, a PD-1 inhibitor, is effective in treating non-small cell lung cancer, especially when combined with chemotherapy. Additionally, cisplatin-based chemotherapy regimens have been shown to reduce mortality and improve survival in patients with non-small cell lung cancer.
12345Is the combination of Fianlimab, Cemiplimab, and Chemotherapy safe for humans?
Pemetrexed, when combined with cisplatin, has shown a favorable safety profile with less frequent and severe side effects compared to other treatments for non-small cell lung cancer. Cemiplimab, used in combination with chemotherapy, is also part of approved treatments for this condition, indicating it has been evaluated for safety in humans.
25678What makes the drug combination of Fianlimab, Cemiplimab, and Chemotherapy unique for treating non-small cell lung cancer?
This treatment is unique because it combines Fianlimab and Cemiplimab, which are newer immunotherapy drugs, with traditional chemotherapy agents like Cisplatin and Paclitaxel, potentially enhancing the immune system's ability to fight cancer while also directly targeting cancer cells.
1391011Eligibility Criteria
Adults with advanced non-small cell lung cancer (NSCLC) who haven't had systemic treatment for recurrent or metastatic NSCLC. They must have a performance status ≤1, indicating they are relatively active and can care for themselves. Participants need to have measurable lung cancer lesions and adequate organ function. Those with certain gene mutations, recent immune suppression treatments, untreated brain metastases, significant autoimmune disease, or prior specific therapies are excluded.Inclusion Criteria
In phase 2, patients need to have their PD-L1 expression tested by an accredited lab. In phase 3, patients need a valid PD-L1 test from a central lab.
I am fully active and can carry on all pre-disease activities without restriction.
My organs and bone marrow are working well.
+3 more
Exclusion Criteria
My tumor has EGFR mutations, ALK translocations, or ROS1 fusions.
I have had lung conditions but not active lung inflammation needing strong medication in the last 5 years.
I have not had systemic therapies except for some exceptions.
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive fianlimab, cemiplimab, and chemotherapy or cemiplimab and chemotherapy
Up to 108 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 5 years
Extension
Participants may continue to be monitored for long-term outcomes and survival
Long-term
Participant Groups
The trial is testing the effectiveness of fianlimab combined with cemiplimab and chemotherapy versus just cemiplimab and chemotherapy in treating advanced NSCLC. It will also examine side effects, drug levels in blood over time, potential antibody development against the drugs, and any impact on quality of life.
5Treatment groups
Experimental Treatment
Group I: Phase 3 - Arm CExperimental Treatment6 Interventions
Randomized 1:1 cemiplimab + platinum-doublet chemotherapy + placebo
Group II: Phase 3 - Arm A or BExperimental Treatment6 Interventions
Randomized 1:1 fianlimab (chosen dose) + cemiplimab + platinum-doublet chemotherapy
Group III: Phase 2 - Arm CExperimental Treatment6 Interventions
Randomized 1:1:1 cemiplimab + platinum-doublet chemotherapy + placebo
Group IV: Phase 2 - Arm BExperimental Treatment6 Interventions
Randomized 1:1:1 fianlimab (lower dose) + cemiplimab + platinum-doublet chemotherapy
Group V: Phase 2 - Arm AExperimental Treatment6 Interventions
Randomized 1:1:1 fianlimab (higher dose) + cemiplimab + platinum-doublet chemotherapy
Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:
🇪🇺 Approved in European Union as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
🇺🇸 Approved in United States as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Basal cell carcinoma (BCC)
- Non-small cell lung cancer (NSCLC)
🇨🇦 Approved in Canada as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
- Non-small cell lung cancer (NSCLC)
🇧🇷 Approved in Brazil as Libtayo for:
- Cutaneous squamous cell carcinoma (CSCC)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
New Mexico Cancer Care AllianceAlbuquerque, NM
Tallahassee Memorial HealthcareTallahassee, FL
Hattisburg ClinicHattiesburg, MS
Bon Secours Cancer Institute RichmondMidlothian, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Regeneron PharmaceuticalsLead Sponsor
References
[Chemotherapy for non-small cell lung cancer]. [2018]The combination of cisplatin and either a vinca alkaloid or etoposide is one of the most effective chemotherapeutic regimens for non-small cell lung cancer. Meta-analyses of clinical trials in which cisplatin-based combination chemotherapy was compared with supportive care in patients with non-resectable non-small cell lung cancer showed that the chemotherapy reduced mortality. In the last decade, new agents, including vinorelbine, edatrexate, paclitaxel, docetaxel, irinotecan, topotecan and gemcitabine, have shown promise in the treatment of non-small cell lung cancer, and new agents combined with platinum compounds have reached the level of phase III testing. Randomized studies in which radiotherapy alone was compared with radiotherapy and cisplatin-based combination chemotherapy in patients with stage III disease showed that combined treatment can prolong survival and improve long-term outcome in patients with locally advanced non-small cell lung cancer. Recently, new agents combined with radiotherapy have been tested. Regimens in which platinum compounds are combined with new agents hold promise for more successful treatment of this disease.
Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. [2023]In metastatic non-small cell lung cancer (NSCLC), tumors that do not harbor driver mutations in EGFR or gene fusions in ALK and ROS, PD-1 and PD-L1 inhibitors have become a cornerstone in first line treatment, either as monotherapy or in combination with chemotherapy. This paper reviews cemiplimab-rwlc, the third PD-1/L1 inhibitor to be approved in the setting for first line treatment in NSCLC, as monotherapy or in combination therapy with chemotherapy, to provide a perspective on the subtle differences in patient population for the cemiplimab studies and consideration of its primary and subgroup results in the context of first line therapies for 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.
PD-1/PD-L1 Inhibitors as Monotherapy in the First-Line Treatment of Advanced Non-Small Cell Lung Cancer Patients with High PD-L1 Expression: An Expert Position Statement. [2023]There are currently three first-line immunotherapy options used as monotherapy in advanced non-small cell lung cancer (NSCLC) patients with high programmed death ligand 1 (PD-L1) expression (≥50%). This manuscript aims to evaluate the available data on atezolizumab (AT), cemiplimab (CEMI), and pembrolizumab (PEMBRO) and to study the results obtained during pivotal trials, especially regarding patient subgroups.
Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. [2022]We aimed to examine cemiplimab, a programmed cell death 1 inhibitor, in the first-line treatment of advanced non-small-cell lung cancer with programmed cell death ligand 1 (PD-L1) of at least 50%.
Pemetrexed plus cisplatin/carboplatin in previously treated locally advanced or metastatic non-small cell lung cancer patients. [2021]The objective of this study was to evaluate the efficacy and safety of pemetrexed plus cisplatin/carboplatin in locally advanced or metastatic non-small cell lung cancer (NSCLC) patients previously treated with platinum-based chemotherapy.
Pemetrexed (Alimta): a new antifolate for non-small-cell lung cancer. [2017]Pemetrexed (Alimta) is a novel multitargeted antifolate that has activity against non-small-cell lung cancer (NSCLC). As a single agent, the response rate is 16%-23%. As second-line therapy, it has a 5% and 14% response rate with pemetrexed in NSCLC patients who have had prior cisplatin or nonplatinum chemotherapy, respectively. Pemetrexed combined with cisplatin has a response rate of 38.9%-44.8%, with a median survival of 8.9-10.9 months. Pemetrexed plus gemcitabine in NSCLC has a response rate of less than 25%. The major toxicity associated with pemetrexed is neutropenia, which may be reduced with vitamin B12 and folate nutritional supplement. Additional studies with pemetrexed in combination with other agents are needed for the treatment of NSCLC patients.
Pemetrexed in advanced NSCLC: a review of the clinical data. [2015]The novel multitargeted antimetabolite pemetrexed (Alimta), recently approved by the US Food and Drug Administration for the treatment of mesothelioma when combined with cisplatin, is also active in first- and second-line non-small-cell lung cancer (NSCLC). In a phase III trial comparing single-agent pemetrexed vs docetaxel (Taxotere) as second-line therapy in advanced NSCLC, survival was shown to be comparable between these agents, but side effects were significantly less frequent and severe for patients who received pemetrexed. In the frontline setting, phase II studies have shown significant activity and a very favorable toxicity profile of the combination of pemetrexed with a platinum agent. Pemetrexed has been well tolerated at systemic doses as a radiosensitizer when given as concurrent chest radiation, and a phase I study is under way to assess its tolerability in combination with carboplatin (Paraplatin) in this setting. Pemetrexed is an important addition to the armamentarium of medicines used to treat thoracic malignancies, and merits study in combination with other drugs having novel mechanisms of action.
[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.
Review of paclitaxel/carboplatin in advanced non-small cell lung cancer. [2015]The management of non-small cell lung cancer (NSCLC) has advanced in the last two decades. The greatest benefit has been achieved with the development of newer chemotherapeutic agents with single-agent response rates > or =20%. Recent research has focused on adding these newer agents to established drugs for NSCLC, like cisplatin and carboplatin, yielding notable improvement in response and survival rates. In particular, experience with the combination of carboplatin plus paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has proved encouraging. This regimen is effective, tolerable, and easy to administer and has produced response rates in NSCLC as high as 62%. Phase III trials are under way to establish the specific role of this regimen in NSCLC. The success of this combination also is being expanded through studies investigating its combination in triplets with newer agents, with follow-up therapy via sequential regimens, and by the addition of biologically based treatments. The results of these trials will determine the preferred treatment approach to NSCLC for the next decade.
Phase II study of paclitaxel, carboplatin, and cetuximab as first line treatment, for patients with advanced non-small cell lung cancer (NSCLC): results of OPN-017. [2018]Cetuximab has demonstrated synergy with taxanes in preclinical models; as well as single agent activity. We assessed the activity of cetuximab with carboplatin and paclitaxel given on a 4-week schedule, in advanced, chemo-naive non-small cell lung cancer.