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Data updated: Nov 8, 2026

PEMETREXED FOR INJECTION (pemetrexed) · Dr. Reddy's

Oncology
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

Details

Status
Prescription
First Approved
N/A
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: PEMETREXED

PEMETREXED FOR INJECTION Approval History

No approval records found

PEMETREXED FOR INJECTION Competitive Set

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Clinical Trial Registry

508 trials
Trial Sponsor ID Phase Status Title
NCT06875310 CA239-0004 2024-515698-85, U1111-1309-5596 Ph 3 recruiting A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)
NCT07005102 M25-287 2024-518586-10 Ph 2, Ph 3 recruiting A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
NCT06151574 1479-0008 2023-504308-27-00, U1111-1294-1407 Ph 3 active not recruiting Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment
NCT03793179 NCI-2018-03695 NCI-2018-03695, EA5163 Ph 3 active not recruiting Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
NCT06772623 M24-536 2024-514465-18, 2024-514465-18-00 Ph 1, Ph 2 recruiting Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations
NCT06694454 10001609 001609-C Ph 1, Ph 2 suspended Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)
NCT05775289 results posted BO44178 Ph 2 completed A Study of Tobemstomig Plus Platinum-Based Chemotherapy vs Pembrolizumab Plus Platinum-Based Chemotherapy in Participants With Previously Untreated Non-Small Cell Lung Cancer
NCT06448754 eVOLVE-01 D798KC00001 2023-509482-20-00, 2023 Ph 2 active not recruiting Volrustomig Priming Regimens Exploratory Phase II Platform Study
NCT05198830 NCI-2021-14403 NCI-2021-14403, CASE1522 Ph 2 active not recruiting 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
NCT03337698 Morpheus Lung results posted BO39610 2017-001267-21 Ph 1, Ph 2 terminated A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)
NCT04245085 ABC-lung results posted ETOP 15-19 MO40586 Ph 2 completed ABC-lung: Atezolizumab, Bevacizumab and Chemotherapy in EGFR-mutant Non-small Cell Lung Carcinoma
NCT06119581 SUNRAY-01 18612 J3M-MC-JZQB, U1111-1288-0565 Ph 3 recruiting A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
NCT06074588 2870-004 2023-503539-16-00, jRCT2031240108 Ph 3 active not recruiting Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
NCT07458347 KST-6051-101 Ph 1 recruiting A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation
NCT03819465 MAGELLAN D933IC00001 2018-001748-74 Ph 1 active not recruiting A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC
NCT03607539 results posted CIBI308C302 Ph 3 completed Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC
NCT06793215 Krascendo 2 CO45042 Ph 3 recruiting A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCT06096844 NCI-2023-08628 NCI-2023-08628, EA5221 Ph 3 recruiting Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
NCT07190248 1084-007 U1111-1307-9569, 2024-514500-14-00 Ph 3 recruiting A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
NCT04538664 PAPILLON results posted CR108850 61186372NSC3001, 2023-506033-29-00 Ph 3 active not recruiting A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions
NCT06632327 CTIU2317-A082304-S2402 NCI-2024-06356 Ph 3 active not recruiting Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer
NCT05870319 SKB264-Ⅲ-09 Ph 3 active not recruiting A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients
NCT06431685 LM-001 Ph 1 recruiting Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer
NCT02609776 CHRYSALIS CR108064 61186372EDI1001, 2018-003908-38 Ph 1 active not recruiting Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer
NCT05498428 PALOMA-2 CR109264 61186372NSC2002, 2022-000526-21 Ph 2 recruiting A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
NCT06459180 2870-020 MK-2870-020, TroFuse-020 Ph 3 active not recruiting A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20)
NCT04988295 MARIPOSA-2 results posted CR109061 61186372NSC3002, 2021-001825-33 Ph 3 active not recruiting A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib Failure
NCT04077463 Chrysalis-2 CR108656 73841937NSC1001, 2020-000747-31 Ph 1 active not recruiting A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer
NCT06312137 TroFuse-019 2870-019 2023-508012-35-00, MK-2870-019 Ph 3 recruiting A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
NCT04083599 GCT1042-01 2018-003716-47, IRAS ID: 263292 Ph 1, Ph 2 active not recruiting GEN1042 Safety Trial and Anti-tumor Activity in Participants With Malignant Solid Tumors
NCT07335497 ASCEND CR-001-101 2025-523590-42-00, 2025 Ph 1, Ph 2 recruiting CR-001 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
NCT07063745 MountainTAP-29 CA240-0029 2025-521511-40, U1111-1319-8383 Ph 2, Ph 3 recruiting A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion
NCT05012254 NIVIPI-Brain GECP 21/02_NIVIPI-Brain 2021-000425-27 Ph 2 active not recruiting Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases
NCT06305754 2870-009 2023-504910-31-00, U1111-1288-3804 Ph 3 active not recruiting Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)
NCT05083481 1570-CL-0101 jRCT2031220527, KEYNOTE-E59 Ph 1 terminated A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors
NCT03456076 results posted BO40336 2017-004331-37, 2017 Ph 3 active not recruiting A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer
NCT06623422 V940-009 2023-506327-29-00, U1111-1293-5814 Ph 3 recruiting A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
NCT05067283 KANDLELIT-001 1084-001 MK-1084-001, jRCT2041220034 Ph 1 recruiting A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
NCT05456256 HARMONIC LTRN300-2LC01-OR21 Ph 2 recruiting A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma
NCT04585490 IRB-54807 LUN0114, NCI-2021-09500 Ph 3 recruiting Adaptive ctDNA-Based Personalization of Treatment During Consolidation Therapy in NSCLC
NCT05118854 2021-0649 NCI-2021-10907 Ph 2 active not recruiting A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation
NCT05624996 NRG-LU008 NCI-2022-08263, NRG-LU008 Ph 3 recruiting Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer
NCT04736173 ARC-10 ARC-10 2020-003562-39, PHRR210222-003371 Ph 2 completed Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer
NCT06996782 ALTAIR D702KC00001 2024-519786-22 Ph 1, Ph 2 recruiting A Platform Study in Non-Small Cell Lung Cancer (NSCLC)
NCT06561386 RELATIVITY1093 CA224-1093 2024-513682-40, U1111-1306-8896 Ph 3 recruiting A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%
NCT05358548 032201 Pro2022000346 Ph 2 recruiting ATATcH Alternating Treatment Plans for Advanced Cancer
NCT02486718 results posted GO29527 2014-003205-15, 2023-505981-26-00 Ph 3 completed Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
NCT03768063 IMbrella B BO40729 2023-506184-34-00, 2023 Ph 3 active not recruiting A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
NCT06630325 results posted STUDY00026643 NCI-2024-07664, STUDY00026643 Ph 2 terminated A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer
NCT06097728 eVOLVE-Meso D7988C00001 2023-503231-17-00, 2023-000067-32 Ph 3 active not recruiting MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

Showing 50 of 508 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PEMETREXED FOR INJECTION FDA Label Details

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.