IPH5201 + Durvalumab + Chemotherapy for Lung Cancer
Recruiting in Palo Alto (17 mi)
+32 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Innate Pharma
Must not be taking: Immunosuppressants, Chemotherapy
Disqualifiers: EGFR mutations, ALK translocations, Autoimmune disorders, others
Stay on Your Current Meds
No Placebo Group
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?The study is intended to assess the safety and efficacy of neoadjuvant combination of IPH5201 and durvalumab in addition to standard chemotherapy and adjuvant combination of IPH5201 and durvalumab in untreated patients with resectable, early-stage (stage II to IIIA) non-small cell lung cancer (NSCLC).
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 take any other chemotherapy, investigational drugs, or immunosuppressive medications during the study.
What data supports the effectiveness of the drug combination IPH5201, Durvalumab, and chemotherapy for lung cancer?
Research shows that Durvalumab, when used alone or with chemotherapy, improves survival in non-small-cell lung cancer (NSCLC) and small-cell lung cancer (SCLC). It is particularly effective as a maintenance therapy after chemoradiotherapy in NSCLC and has shown significant survival benefits in combination with chemotherapy in SCLC.
12345Is the combination of IPH5201, Durvalumab, and chemotherapy generally safe for humans?
Durvalumab, a part of this treatment, has been shown to have a manageable safety profile in lung cancer patients, but it can cause immune-related side effects like pneumonitis (lung inflammation), which can be serious. About 25% of patients in a study experienced immune-related side effects, with 3.4% having severe reactions.
12678What makes the drug combination of IPH5201, Durvalumab, and chemotherapy unique for lung cancer?
This treatment combines Durvalumab, an immune checkpoint inhibitor that blocks PD-L1 to help the immune system attack cancer cells, with IPH5201, a novel antibody targeting CD39, and standard chemotherapy. This combination aims to enhance the immune response against lung cancer, potentially offering a new approach for patients who may not respond well to existing treatments.
124910Eligibility Criteria
This trial is for patients with early-stage (II to IIIA) non-small cell lung cancer that can be surgically removed. They must have proper organ function, not be pregnant, and agree to use contraception. Excluded are those with small-cell lung cancer, certain genetic mutations, autoimmune diseases, another primary malignancy, or severe cardiovascular disease.Inclusion Criteria
You are expected to live for at least 12 more weeks.
I am using birth control during the study period.
My organs and bone marrow are working well.
+8 more
Exclusion Criteria
I have not received a live vaccine in the last 30 days.
I have previously been given durvalumab or IPH5201 in this study.
Participation in another clinical study with an investigational product administered within 30 days prior to enrolment
+23 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Neoadjuvant Treatment
Participants receive neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy before surgery
16 weeks
Multiple visits for treatment administration
Surgery
Participants undergo surgical resection
1 week
1 visit for surgery
Adjuvant Treatment
Participants receive adjuvant treatment with IPH5201 and durvalumab post-surgery
Up to 4 months
Multiple visits for treatment administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 2 years
Regular follow-up visits
Participant Groups
The study tests the combination of IPH5201 and durvalumab with standard chemotherapy before surgery (neoadjuvant therapy), followed by the same drugs after surgery (adjuvant therapy). It aims to evaluate safety and effectiveness in untreated NSCLC patients eligible for tumor removal.
1Treatment groups
Experimental Treatment
Group I: IPH5201 + durvalumab + standard chemotherapyExperimental Treatment1 Intervention
Patients will receive Neoadjuvant therapy with IPH5201 and durvalumab in addition to standard chemotherapy.
Following surgery, patients will receive adjuvant treatment with IPH5201 and durvalumab.
Durvalumab is already approved in European Union, United States, Japan for the following indications:
🇪🇺 Approved in European Union as Imfinzi for:
- Locally advanced, unresectable non-small cell lung cancer (NSCLC)
🇺🇸 Approved in United States as Imfinzi for:
- Extensive-stage small cell lung cancer (ES-SCLC)
- Limited-stage small cell lung cancer (LS-SCLC)
- Locally advanced or metastatic urothelial carcinoma
🇯🇵 Approved in Japan as Imfinzi for:
- Not specified in provided sources
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Allegheny General HospitalPittsburgh, PA
UW Carbone Cancer CenterMadison, WI
St. Anthony's Hospital - BayCare Health SystemSaint Petersburg, FL
H. Lee Moffitt Cancer Center & Research InstituteTampa, FL
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Innate PharmaLead Sponsor
References
Durvalumab in non-small-cell lung cancer patients: current developments. [2018]Immune checkpoint inhibitors (ICIs) are a key component of treating advanced cancer patients, principally antibodies against CTLA-4 and PD-1 or PD-L1. Durvalumab (MEDI4736) is a selective, high-affinity, human IgG1 monoclonal antibody that blocks PD-L1, which binds to PD-1 and CD80, but not to PD-L2. Single-agent durvalumab showed clinical efficacy and a manageable safety profile in advanced non-small-cell lung cancer, particularly the ≥25% PD-L1+ population. Durvalumab is under evaluation in early, locally advanced and advanced disease as monotherapy and combined with ICIs, targeted therapies, chemotherapy and radiotherapy. Impressive activity has been recently reported after chemoradiation in locally advanced patients; promising activity was observed with other ICI combinations, and potentially with other drugs including platinum-based chemotherapy. In contrast, early data reveal lower response rates in EGFR and ALK-positive patients.
Update on Targeted Therapies for Advanced Non-Small Cell Lung Cancer: Durvalumab in Context. [2020]Immune checkpoint inhibitors (ICIs) have transformed the therapeutic strategy and prognosis of advanced non-small cell lung cancer (NSCLC) patients. Nowadays, ICIs as monotherapy or in combination with chemotherapy are the standard of care treatment in advanced NSCLC, and in stage III, durvalumab (a programmed death ligand 1 inhibitor) is the unique drug approved as consolidation treatment after chemo-radiotherapy. This article reviews the pharmacological properties, clinical activity and safety of durvalumab as monotherapy or in combination with chemotherapy or other ICIs in the therapeutic strategy of NSCLC patients.
Patient-reported outcomes with durvalumab, with or without tremelimumab, plus chemotherapy as first-line treatment for metastatic non-small-cell lung cancer (POSEIDON). [2023]In the phase 3 POSEIDON study, first-line tremelimumab plus durvalumab and chemotherapy significantly improved overall survival and progression-free survival versus chemotherapy in metastatic non-small-cell lung cancer (NSCLC). We present patient-reported outcomes (PROs).
Safety evaluation of durvalumab for the treatment of non-small-cell lung cancer. [2022]The development of immune checkpoint inhibitors (ICIs), such as anti-programmed death 1/programmed death ligand 1 (PD-1/PD-L1) inhibitors, has been a breakthrough in the treatment of non-small-cell lung cancer (NSCLC). Durvalumab, a PD-L1 inhibitor, has shown survival benefit as a maintenance therapy for patients with unresectable stage III NSCLC following definitive chemoradiotherapy, and is approved by the U.S. Food and Drug Administration and the European Medicines Agency.
Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study. [2021]In the phase III CASPIAN study, first-line durvalumab plus etoposide in combination with either cisplatin or carboplatin (EP) significantly improved overall survival (primary endpoint) versus EP alone in patients with extensive-stage small-cell lung cancer (ES-SCLC) at the interim analysis. Here we report patient-reported outcomes (PROs).
Characterizing immune-mediated adverse events with durvalumab in patients with unresectable stage III NSCLC: A post-hoc analysis of the PACIFIC trial. [2022]Immune-mediated adverse events (imAEs), including all-cause immune-mediated pneumonitis, were reported in approximately 25% of patients in the placebo-controlled, phase III PACIFIC trial of durvalumab monotherapy (for up to 12 months) in patients with unresectable, stage III NSCLC and no disease progression after concurrent chemoradiotherapy; only 3.4% of patients experienced grade 3/4 imAEs. With broad application of the PACIFIC regimen (consolidation durvalumab after chemoradiotherapy), now standard-of-care in this setting, there is a need to better characterize the occurrence of imAEs with this regimen.
Safety and efficacy of durvalumab (MEDI4736) in various solid tumors. [2022]The prominent immune checkpoint molecule, programmed cell death ligand-1 (PD-L1), is the object of increasing attention. Here, we report a meta-analysis investigating the safety and efficacy of durvalumab (MEDI4736), an inhibitor of PD-L1, in various solid tumors.
Real-World Incidence of Pneumonitis in Patients Receiving Durvalumab. [2022]Durvalumab is a programmed cell death ligand 1 (PD-L1) inhibitor indicated for stage III, unresectable non-small cell lung cancer (NSCLC) consolidation therapy following concurrent platinum-based chemoradiation based on results of the PACIFIC trial. Safety data of durvalumab demonstrates an increased risk of immune-related adverse effects (irAEs), most notably pneumonitis. Pneumonitis is a serious and potentially fatal complication of immunotherapy. It is important to investigate the incidence of pneumonitis in clinical practice to evaluate the generalizability of published data. The objective of this study is to assess and characterize real-world incidence of pneumonitis in patients with NSCLC receiving durvalumab.
Durvalumab: A Review in Extensive-Stage SCLC. [2022]Durvalumab (IMFINZI®), a fully human monoclonal antibody against programmed cell death-ligand 1 (PD-L1), is approved for use in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). In the pivotal phase III CASPIAN trial in previously untreated adults with ES-SCLC, the addition of durvalumab to chemotherapy for up to 4 cycles followed by maintenance durvalumab was associated with a significantly longer overall survival and a favourable hazard ratio for progression-free survival compared with chemotherapy alone for up to 6 cycles. A higher proportion of patients in the durvalumab plus chemotherapy group had an objective response compared with the chemotherapy alone group. The efficacy of durvalumab was also sustained with longer follow-up. Durvalumab in combination with etoposide and either carboplatin or cisplatin had a manageable tolerability profile in patients with ES-SCLC. Given the available evidence, durvalumab in combination with etoposide and either carboplatin or cisplatin represents a valuable treatment option for the first-line treatment of patients with ES-SCLC, and is an accepted standard of care option in this setting.
Durvalumab for the treatment of non-small cell lung cancer. [2019]In non-small cell lung cancer (NSCLC), immunotherapy is one of today's most important and ground-breaking systemic treatments, mainly represented by antibodies against cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and programmed death protein 1 or ligand 1 (PD-1/PD-L1). Durvalumab (MEDI4736) is a high-affinity human IgG1 monoclonal antibody that binds to PD-1 and CD80, blocking PD-L1, but not PD-L2. Areas covered: In advanced NSCLC patients, durvalumab has demonstrated activity and acceptable tolerability, particularly with ≥25% PD-L1 tumor expression in the EGFR and ALK wild-type population. However, preliminary data have shown lower efficacy in EGFR mutant and ALK-positive patients. The results from the recent PACIFIC study in locally advanced patients have placed durvalumab as standard of care in consolidation after chemoradiation, leading to Food and Drug Administration (FDA) approval. Expert commentary: Early data suggest promising activity for durvalumab with the CTLA-4 inhibitor tremelimumab, regardless of PD-L1 expression, and potentially in combination with other drugs such as platinum-doublet chemotherapy. However, treatment-related toxicity associated with the combinations is an important aspect of the benefit-risk evaluation in the decision-making process. Results of ongoing phase III trials will provide illuminating data to confirm the place of durvalumab in the management of NSCLC patients.