Pemfexy (pemetrexed) / Eagle Pharma - LARVOL DELTA

NCI-2015-00693: Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination with Multiple Standard Chemotherapy or Immunotherapy Agents in Patients with Advanced Malignancies (clinicaltrials.gov) - P1 | N=221 | Terminated | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Dec 2024 ➔ Sep 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2024 ➔ Sep 2024; Administratively Complete

Combination therapy • IO biomarker • Metastases • Trial completion date • Trial primary completion date • Trial termination • Breast Cancer • Cutaneous Melanoma • Fallopian Tube Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma • Solid Tumor • Triple Negative Breast Cancer

ENDURE: Local Consolidative Therapy and Durvalumab for Oligoprogressive and Polyprogressive Stage III NSCLC After Chemoradiation and Anti-PD-L1 Therapy (clinicaltrials.gov) - P2 | N=51 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Sep 2024 ➔ Sep 2026 | Trial primary completion date: Sep 2024 ➔ Sep 2026

Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • MET • RET • ROS1

Chemotherapy Combined With Immunotherapy vs Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial (clinicaltrials.gov) - P3 | N=304 | Recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Nov 2024 ➔ Jul 2024

Metastases • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • ALK • EGFR • PD-L1

Lung-MAP Sub-Study: Testing the Use of Targeted Treatment for RET Positive Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: SWOG Cancer Research Network | N=74 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Metastases • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • KRAS • MET • RET • ROS1

Lung-MAP Sub-Study: Testing the Use of Targeted Treatment for RET Positive Advanced Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=74 | Recruiting | Sponsor: SWOG Cancer Research Network | Trial primary completion date: May 2028 ➔ Jun 2023

Metastases • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • KRAS • MET • RET • ROS1

Testing the Addition of an Anti-Cancer Drug, TRC102, to the Usual Chemotherapy Treatment (Pemetrexed, Cisplatin or Carboplatin) During Radiation Therapy for Stage III Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: National Cancer Institute (NCI) | N=78 ➔ 42

Combination therapy • Enrollment change • Lung Adenocarcinoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4

Chemotherapy Combined With Immunotherapy vs Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial (clinicaltrials.gov) - P3 | N=304 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2024 ➔ Nov 2024

Enrollment open • Metastases • Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • ALK • EGFR • PD-L1

EA5163: Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=600 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Biomarker • Combination therapy • Enrollment closed • IO biomarker • Metastases • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • PD-L1 • ROS1

Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Phase classification: P1b ➔ P1

Combination therapy • Phase classification • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Platinum Doublet Chemotherapy and Proton Beam Radiation Therapy in Treating Patients With Stage II-III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=18 | Completed | Sponsor: Mayo Clinic | Active, not recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Dec 2023 | Trial primary completion date: Jun 2024 ➔ Dec 2023

Surgery • Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Platinum Doublet Chemotherapy and Proton Beam Radiation Therapy in Treating Patients With Stage II-III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2 | N=18 | Active, not recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Dec 2023 ➔ Jun 2024

Surgery • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NEOSTAR: Nivolumab With or Without Ipilimumab or Chemotherapy in Treating Patients With Previously Untreated Stage I-IIIA Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=101 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Jul 2024 ➔ Dec 2024

Checkpoint block • Checkpoint inhibition • IO biomarker • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Melissa Johnson, MD, Shares Insights on Lung Cancer Clinical Trials, ‘Practice-Changing’ Treatments (DocWire) - "There were so many great scientific abstracts reported at ESMO 2023. The two that jump out to me are the ALINA trial, in which patients with resected non-small cell lung cancer (NSCLC) with ALK rearrangements were randomized to receive the ALK tyrosine kinase inhibitor (TKI) alectinib or chemotherapy...That finding corresponded to the risk of central nervous system (CNS) recurrence, which was also 80% reduced for patients who received the TKI....I could go on for a long time about the abstracts from ESMO 2023...At the World Conference on Lung Cancer, it was reported that the response rate for patients was around 30% for those with EGFR-mutated NSCLC...It is an additional therapy to give hope to our patients."

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Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Ohio State University Comprehensive Cancer Center | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Combination therapy • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: SCRI Development Innovations, LLC | N=15 ➔ 0 | Recruiting ➔ Withdrawn

Combination therapy • Enrollment change • Metastases • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07) (clinicaltrials.gov) - P3 | N=975 | Recruiting | Sponsor: Daiichi Sankyo, Inc.

Metastases • Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • BRAF • EGFR • PD-L1 • RET • ROS1 • TACSTD2

Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=10 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Apr 2024 ➔ Sep 2024

Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Investigators Deliver Updates on Evolving Clinical Trials Evaluating ADCs in Lung Cancer (OncLive) - "We're seeing for the first time [with ifinatamab deruxtecan] that ADCs work-not just in NSCLC, but also in SCLC,' Melissa L. Johnson, MD, said. 'We often worry that so many of our breakthrough discoveries happen for patients with NSCLC, so it's wonderful when things work for SCLC, too. I am optimistic about this agent in this group of patients....Regarding next steps for the research, Janne noted that 'this trial was in patients who had received prior systemic therapy [and] there is an ongoing trial of trastuzumab deruxtecan vs combination chemotherapy plus immune checkpoint inhibition as first-line therapy for patients with stage IV HER2-mutated NSCLC. The efficacy is quite good and it’s what we are used to seeing for the targeted therapy patient population; the purpose of the [phase 3] DESTINY-Lung04 trial [NCT05048797] is to see whether it will be even higher or better than the standard of care in the first-line setting."

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Chemotherapy Combined With Immunotherapy vs Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial (clinicaltrials.gov) - P3 | N=304 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

Metastases • New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Psoriatic Arthritis • Solid Tumor • ALK • EGFR • PD-L1

Eagle Pharmaceuticals Granted Patent for PEMFEXY (GlobeNewswire) - "Eagle Pharmaceuticals, Inc...today announced that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No. 11,793,813 ('the ‘813 patent') entitled 'Pemetrexed Formulations.' Eagle has submitted the patent for listing in the U.S. Food and Drug Administration’s Orange Book. The ‘813 patent is directed to pemetrexed formulations, including the FDA-approved commercial formulation of PEMFEXY."

Patent • Oncology • Solid Tumor

G360-IIT: Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy (clinicaltrials.gov) - P2 | N=108 | Recruiting | Sponsor: Hackensack Meridian Health | Not yet recruiting ➔ Recruiting

Circulating tumor DNA • Enrollment open • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer (clinicaltrials.gov) - P1/2 | N=25 | Recruiting | Sponsor: Vanderbilt-Ingram Cancer Center | Suspended ➔ Recruiting

Enrollment open • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

Split Course Adaptive Radiation Therapy With Pembrolizumab With/Without Chemotherapy for Treating Stage IV Lung Cancer (clinicaltrials.gov) - P1/2 | N=25 | Suspended | Sponsor: Vanderbilt-Ingram Cancer Center | Recruiting ➔ Suspended

IO biomarker • Metastases • Trial suspension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-1 • PD-L1

Testing the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy Treatment During Radiation Therapy for Superior Sulcus Non-small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: National Cancer Institute (NCI) | N=60 ➔ 0 | Active, not recruiting ➔ Withdrawn

Enrollment change • Surgery • Trial withdrawal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib (clinicaltrials.gov) - P2 | N=15 | Recruiting | Sponsor: SCRI Development Innovations, LLC | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor