Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below.

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Results 1 - 10 of 54

Phase III Trial of Stereotactic Radiosurgery (SRS) versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for Brain Metastases from Small Cell Lung Cancer
Objective:

Primary Objective

Determine whether stereotactic radiosurgery (SRS) relative to whole brain radiotherapy with hippocampal avoidance (HA-WBRT) plus memantine for brain metastases from small cell lung cancer (SCLC) prevents cognitive function failure as measured by cognitive decline on a battery of tests: the Hopkins Verbal Learning Test – Revised (HVLT-R), Controled Oral Word Association (COWA) test, and the Trail Making Test (TMT).

Secondary Objectives

Determine whether SRS relative to HA-WBRT plus memantine for brain metastases from SCLC preserves cognitive function as separately measured by the HVLT-R, COWA, TMT Parts A and B, and Clinical Trial Battery Composite (CTB COMP).

Assess perceived difficulties in cognitive abilities using PROMIS after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

Assess symptom burden using the MD Anderson Symptom Inventory for brain tumor (MDASI-BT) after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

Compare cumulative incidence of intracranial disease progression after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

Compare overall survival after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

Compare cumulative incidence of neurologic death after SRS relative to HA-WBRT plus memantine for brain metastases from SCLC.

Compare the number of salvage procedures used to manage recurrent intracranial disease following SRS relative to HA-WBRT plus memantine for SCLC brain metastases.

Compare adverse events between the treatment arms according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.

Compare the risk of developing cerebral necrosis between SRS and HA-WBRT plus memantine in patients receiving concurrent immunotherapy.
Cancer Categories:
Brain and Nervous System,Lung
Principal Investigator:
Dominello, Michael
Karmanos Trial ID:
NRG-CC009
Age Group:
Adult
Phase:
Phase III
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Randomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial
Objective:

Primary Objective

Phase II:

To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone

Phase III:

To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone

Secondary Objectives

To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm

To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and >3 visible tumors

To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease (“complete consolidation”) and patients who do not receive consolidation radiation to all visible disease (“incomplete consolidation”)
Cancer Categories:
Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-LU007
Age Group:
Adult
Phase:
Phase II/III
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A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) with Homozygous MTAP Deletion After Progression on Prior Therapies
Objective:

Part 1: Dose Selection

Primary Objective:

To evaluate investigator-assessed objective response (OR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

Secondary Objectives:

To evaluate investigator-assessed disease control (DC) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed clinical benefit (CB) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed duration of response (DOR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed progression-free survival (PFS) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To evaluate investigator-assessed time to objective response (TTOR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

To assess the safety and tolerability of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

Part 2 + Selected Dose from Part 1

Primary Objective:

To evaluate OR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

Secondary Objectives:

To evaluate investigator-assessed OR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate DC of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed DC of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate CB of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed CB of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate PFS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed PFS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate TTOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed TTOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate DOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To evaluate investigator-assessed DOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To assess OS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To assess the safety and tolerability of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

To assess the impact of disease symptoms and treatment on participant’s healthrelated quality-of-life in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
Cancer Categories:
Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2025-053
Age Group:
Adult
Phase:
Phase II
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A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of BL-M07D1 in Subjects with HER2 Expressing Advanced Malignant Solid Tumors
Objective:

Primary Objectives:

To assess the safety and tolerability of BL-M07D1 in metastatic or unresectable HER2-expressing tumors

To determine the MTD if reached or MAD and two or more RDEs of BL-M07D1

Secondary Objectives:

To characterize the pharmacokinetics of BL-M07D1, total anti-HER2 antibody, and payload (Ed-04)

To investigate the antitumor activity of BL-M07D1
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-010
Age Group:
Adult
Phase:
Phase I
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A Phase 1, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Pralatrexate in Patients with Advanced Solid Tumor or Hematological Malignancy and either Normal Hepatic Function or Mild, Moderate, or Severe Hepatic Impairment
Objective:

Primary Objective

To evaluate the pharmacokinetic (PK) profile of pralatrexate when administered to patients with various degrees of hepatic impairment

Secondary Objectives

To evaluate the safety of pralatrexate when administered once weekly for 6 weeks of every 7-week treatment cycle

To establish the dosing recommendations for pralatrexate administered once weekly for 6 weeks of every 7-week treatment cycle in patients with hepatic impairment
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Lung
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-029
Age Group:
Adult
Phase:
Phase I
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A Phase 3 Study of the selective anaplastic lymphoma kinase (ALK) inhibitor NVL-655 compared to alectinib in first-line treatment of patients with ALK-positive advanced non-small cell lung cancer (ALKAZAR)
Objective:

Primary Objective:

To evaluate the efficacy of NVL-655 compared to alectinib in patients with treatment-naïve ALK-positive advanced NSCLC

Secondary Objectives:

To assess additional measures of efficacy of NVL-655 compared to alectinib in patients with treatment-naïve ALK-positive advanced NSCLC

To evaluate the safety and tolerability of NVL-655 compared to alectinib

To evaluate and compare patient-reported measures of health-related quality of life (QoL), lung cancer symptoms, patient functioning, and side effects of treatment
Cancer Categories:
Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2025-054
Age Group:
Adult
Phase:
Phase III
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A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM16390, as a Single Agent and in Combination with pembrolizumab, in Patients with Advanced or Metastatic Solid Tumors
Objective:

Primary Objective:

To evaluate the safety and tolerability of HM16390 administered SC in subjects with advanced or metastatic solid tumors

Secondary Objectives:

To determine the MTD or recommended Phase II dose (RP2D) of HM16390 administered SC in subjects with advanced or metastatic solid tumors

To characterize the PK of HM16390 SC administration in subjects with advanced or metastatic solid tumors

To assess the anti-tumor effect of HM16390 SC administration in subjects with advanced or metastatic solid tumors
Cancer Categories:
Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin
Principal Investigator:
Saif, Wasif
Karmanos Trial ID:
2025-024
Age Group:
Adult
Phase:
Phase I
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A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene
Objective:

Primary Objective:

To determine the recommended dose for Part 2 (RP2D) and to assess the efficacy of WSD0922-FU by assessment of ORR by RECIST v1.1.

Secondary Objectives:

To further assess the efficacy of WSD0922-FU in terms of: - Progression Free Survival (PFS) - Duration of Response (DoR) - Disease Control Rate (DCR) - Change in Tumor Size - Overall Survival (OS)

To assess the effect of WSD0922-FU on patients’ disease-related symptoms and health related quality of life (HRQoL).

To characterize the PK of WSD0922-FU and metabolites in patients receiving WSD0922-FU.
Cancer Categories:
Lung
Principal Investigator:
Uprety, Dipesh
Karmanos Trial ID:
2025-045
Age Group:
Adult
Phase:
Phase II
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A Phase III Randomized Clinical Trial of Proton Craniospinal Irradiation Versus Involved-Field Radiotherapy for Patients with Breast Cancer or Non-Small Cell Lung Cancer Leptomeningeal Metastasis (RADIATE-LM)
Objective:

Primary Objective:

To compare overall survival (OS) between proton craniospinal irradiation (pCSI) and involved-field radiotherapy (IFRT) in patients with breast cancer or non-small cell lung cancer (NSCLC) leptomeningeal metastasis.

Secondary Objectives:

To compare central nervous system progression-free survival (CNS PFS) between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis.

To compare time to CNS progression between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis.

To compare CNS PFS between pCSI and IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis, as evaluated by central review of imaging.

To compare the rate of radiation-induced central nervous system necrosis between pCSI vs. IFRT in patients with breast cancer or NSCLC leptomeningeal metastasis.

To characterize treatment-related adverse events using CTCAE v5.0.

To compare patient-reported outcomes (Symptoms Severity subscale per MDASI-BT and MDASI-SP) in patients with breast cancer or non-small cell lung cancer leptomeningeal metastasis
Cancer Categories:
Breast,Lung
Principal Investigator:
Yeh, Brian
Karmanos Trial ID:
NRG-BN014
Age Group:
Adult
Phase:
Phase III
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A Phase III, Open-label, Randomised Study of Osimertinib with or without Datopotamab Deruxtecan (Dato-DXd), as First-line Treatment in Participants with Epidermal Growth Factor Receptor (EGFR) Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (TROPION-Lung14)
Objective:

Safety Run-in Period

Primary Objectives:

To assess the safety and tolerability of osimertinib in combination with Dato-DXd in all dosed safety run-in participants.

Secondary Objectives:

To demonstrate the effectiveness of osimertinib in combination with Dato-DXd by assessment of ORR in all dosed safety run-in participants with measurable disease at baseline.

To demonstrate the effectiveness of osimertinib in combination with Dato-DXd by assessment of DoR in all dosed safety run-in participants with measurable disease at baseline.

To assess the PK of osimertinib and DatoDXd.

To investigate the immunogenicity for DatoDXd

Randomisation Period

Primary Objectives:

To demonstrate the superiority of osimertinib in combination with Dato-DXd relative to osimertinib by assessment of PFS by BICR in all randomised participants.

Secondary Objectives:

To demonstrate the superiority of osimertinib in combination with Dato-DXd relative to osimertinib by assessment of OS in all randomised participants.

To demonstrate the effectiveness of osimertinib in combination with Dato-DXd relative to osimertinib by assessment of CNS PFS by CNS BICR in participants with CNS metastases at baseline.

To demonstrate the effectiveness of osimertinib in combination with Dato-DXd relative to osimertinib by assessment of PFS by investigator in all randomised participants.

To demonstrate the effectiveness of osimertinib in combination with Dato-DXd relative to osimertinib by assessment of ORR in all randomised participants with measurable disease at baseline.

To demonstrate the effectiveness of osimertinib in combination with Dato-DXd relative to osimertinib by assessment of DoR in all randomised participants with measurable disease at baseline.

To demonstrate the effectiveness of osimertinib in combination with Dato-DXd relative to osimertinib on the prevention of CNS metastases.

To demonstrate the effectiveness of osimertinib in combination with Dato-DXd relative to osimertinib by assessment of PFS2 in all randomised participants

To assess the PK of osimertinib and DatoDXd.

To investigate the immunogenicity of DatoDXd.

To compare the local EGFR mutation test result used for patient selection with the retrospective central cobas® EGFR Mutation Test v2 results from baseline tumour samples.

To demonstrate the effectiveness of osimertinib in combination with Dato-DXd vs. osimertinib monotherapy based on the cobas® EGFR Mutation Test v2 plasma screening test result for Ex19del or L858R EGFR mutations.
Cancer Categories:
Lung
Principal Investigator:
Mamdani, Hirva
Karmanos Trial ID:
2025-017
Age Group:
Adult
Phase:
Phase III
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