NRG-CC011 Cognitive Training for Breast Cancer Survivors
Sponsor: NRG
Study: NRG-CC011
Cancer Stage: Stage I-III

Description: Cognitive Training For Cancer Related Cognitive Impairment In Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial

Inclusions:

• First time diagnosis of non-metastatic breast cancer stage I-III

Exclusions:

• Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer’s disease or other dementia
• Active substance abuse and/or in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability.

Prior treatment: 

• Allowed

Purpose: 

• The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction.

Basic Qualifications: 

• First time diagnosis of non-metastatic breast cancer

NRG-CC011 Brochure

NRG-CC014
Sponsor: NRG Oncology
Study: CC014
Cancer Stage: Stage IV

Description: Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT) (NCT#06745024)

Inclusions:

• Patients with polymetastatic cancer defined as more than 5 sites of radiographically evident systemic metastatic disease.
• Patients with any solid tumor type
• Patients must have systemic disease

Exclusions:

• No previous radiotherapy to the intended enrolled sites of disease.
• No prior fracture at the enrolled bone metastasis(es).

Prior treatment:

• NA

Purpose:

• To determine whether prophylactic radiation therapy (RT) to high-risk asymptomatic bone metastases decreases the occurrence of skeletal-related events (SREs), including pathologic fracture, spinal cord compression, and surgery to bone (not including palliative radiation for pain only), compared to standard of care (SOC).

Basic Qualifications:

• Same as inclusion criteria

Resources:

• AMD patient brochure v002825

NRG-GY028
Sponsor: NRG
Study: GY028
Cancer Stage: Recurrent or Metastatic Endometrioid Endometrial Cancer

Description: A Phase IB and Randomized Phase II Trial of Megestrol Acetate with or Without Ipatasertib in Recurrent or Metastatic Endometrioid Endometrial Cancer.

Inclusions:

• Patients must have grade 1 or 2 recurrent or metastatic endometrioid endometrial cancer.
• Measurable disease
• ECOG 0-2

Exclusions:

• Listed in protocol

Prior treatment: 

• Allowed

Purpose: 

• To compare the progression free survival of the combination of ipatasertib with megestrol acetate to megestrol acetate alone among women with metastatic grade 1-2 endometrioid adenocarcinoma of the endometrium.

Basic Qualifications: 

• See inclusions

XPORT-EC-042
Sponsor: Karyopharm Therapeutics Inc.
Study: XPORT-EC-042
Cancer Stage: Advanced or Recurrent Endometrial Carcinoma

Description: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial of Selinexor in Maintenance Therapy After Systemic Therapy for Patients With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Inclusions:

• TP53 Wildtype
• Contact research staff

Exclusions:

• Any uterine sarcomas (carcinosarcomas – not excluded), clear cell or small cell carcinoma with neuroendocrine differentiation.

Prior treatment: 

• Allowed

Purpose: 

• To evaluate efficacy and safety for maintenance administration of Selinexor in patients with TP53 wildtype (no TP53 alterations) advanced or recurrent Endometrial Carcinoma

Basic Qualifications: 

• See inclusions

NRG-GY036
Sponsor: NRG Oncology
Study: GY036
Cancer Stage: Stage III-IV BRCA 1/2 or HDR+ Ovarian Cancer

Description: A Phase III Trial of One vs. Two Years of Maintenance Olaparib, with or Without Bevacizumab, in Patients with BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy (NCT#06580314)

Inclusions:

• Patients with newly diagnosed, pathologically confirmed, FIGO Stage III or IV ovarian cancer
• Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic OR
• BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, CLIA-certified laboratory

Exclusions:

• No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib.

Prior treatment:

• Patient must have undergone cytoreductive surgery (primary or interval)
• Patients must have completed first line platinum-based therapy prior to registration

Purpose:

• To determine investigator assessed progression-free survival using RECIST v1.1 (noninferiority) for one vs. two years of maintenance olaparib.

Basic Qualifications:

• Same as inclusion criteria

NRG-HN014
Sponsor: NRG Oncology
Study: HN014
Cancer Stage: Stage III/IV

Description: Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response Adapted Treatment versus Standard of Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

Inclusions:

• Pathologically (histologically or cytologically) proven diagnosis of invasive Cutaneous Squamous Cell Carcinoma (CSCC)
• Stage III or IV
• Primary tumor site must be in the head and neck cutaneous region, other non-head and neck cutaneous regions, or eyelid cutaneous region
• Tumor must be resectable with curative intent
• At least 1 lesion that is measurable
• ECOG Performance Status 0-2

Exclusions:

• Mucosal Squamous Cell Carcinoma
• Tumor with bony skull base invasion and/or skull base foramen involvement (T4b) is not eligible.

Prior treatment:

• No prior radiotherapy to the region of cancer
• No prior systemic therapy for the study cancer

Purpose: 

• To determine if neoadjuvant immunotherapy combined with response-adapted oncologic surgery improves site-reported event-free survival (EFS) compared to standard-of-care surgery in resectable stage III/IV CSCC.

Basic Qualifications: 

• Same as inclusion criteria

NRG-HN014 Patient Brochure

MGT-AQP1-201-Gene Therapy for Radiation-Induced Xerostomia
Sponsor: MeiraGTX
Study: MGT-AQP1-201
Cancer Stage: Head & Neck Cancer Radiation Induced late Xerostomia (Dry Mouth)

Description: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia

Inclusions:

• Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit
• No history of parotid gland cancer, recurrent cancer, or a second primary cancer

Exclusions:

• Any malignancy within the preceding 3 years, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma

Prior treatment:

• No previous treatment with a gene or cell therapy for Xerostomia

Purpose:

• Treatment of symptoms of Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract (i.e., the lip, tongue, oral cavity, nasal cavity/sinuses, nasopharynx, oropharynx, hypopharynx, and larynx), excluding the parotid glands

Basic Qualifications: 

• See inclusions

MGT-AQP1-201-Gene Therapy for Radiation-Induced Xerostomia Patient Brochure

PROSPECT LUNG
Sponsor: Alliance
Study: CTIU2317-A082304-S2402
Cancer Stage: Stage IIA to IIIB

Description: Perioperative Versus Adjuvant Systemic Therapy in Patients with Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG (NCT#06632327)

Inclusions:

• Histologically or cytologically confirmed surgically resectable stage IIA to IIIB NSCLC
• Patients with resectable stage N2a or T4

Exclusions:

• No prior systemic treatment for NSCLC within 5 years except stage 1 and 2 cancers treated with curative intent.
• Patients with known EGFR or ALK alterations.
• Patients with stage N2b or N3.

Prior treatment:

• NA

Purpose:

• To compare the 3-year real-world event-free survival (rwEFS) rate and overall survival (OS) between perioperative and adjuvant immunotherapy-based treatment for patients with resectable non-small cell lung cancer.

Basic Qualifications:

• Same as inclusion criteria

Resources:

• CTIU RecMat Flyer
• CTIU2317 RecMat Lung Patient Info Sheet

NRG-BN013
Sponsor: NRG Oncology
Study: BN013
Cancer Stage: Metastatic

Description: A Phase III trial for brain metastases

Inclusions:

• Pathologically (histologically or cytologically) proven diagnosis of one of the following cancers
  • Non-small cell lung
  • Melanoma
  • Breast
  • Renal cell
  • Gastrointestinal
• Must have at least 1 and up to 8 total intact brain metastases on MRI and outside of the brainstem

Exclusions:

• No prior radiotherapy to the brain

Prior treatment:

• No prior radiotherapy to the brain

Purpose:

• To determine if the time to local failure is improved with FSRS compared to SRS in patients with intact (i.e., unresected) brain metastases

Basic Qualifications:

• Same as inclusion criteria

GCP-PRT-101-001 for solid tumors with brain mets
Sponsor: Radiopharm Therano
Study: GCP-PRT-101-001
Cancer Stage: Suspected Recurrent Brain Metastases from Solid Tumors

Description: An Open-Label, Single Dose, Single Arm, Multicenter Phase 2b Study to Establish the Imaging Performance of RAD101 Positron Emission Tomography (PET) in Participants with Suspected Recurrent Brain Metastases from Solid Tumors.

Inclusions:

• One of the following histopathologically confirmed advanced solid tumors with known history of brain metastases: lung, breast, colon, kidney, or melanoma.
• Participant had SRS within up to 12 months prior to screening
• Suspected brain metastasis in at least 1 but not more than 5 previously treated brain mets

Exclusions:

• Brain surgery within 4 weeks before screening

Prior treatment: 

• Allowed

Purpose: 

• To establish the imaging performance of RAD101 PET in participants with suspected recurrent brain metastases from solid tumors.

Basic Qualifications: 

• See inclusions

Tempus ARIES Trial- Biobank Registry
Sponsor: Tempus AI, Inc.
Study: TP-CA-007
Cancer Stage: Various cohorts available

Description: A Biobank Registry Platform Study in Oncology. This Study is a multisite, multicohort, master biospecimen collection non-interventional Study using participant data and blood samples at prospectively defined time points for ctDNA analysis to answer cohort-based research questions. The Study will not affect participants’ clinical care or access to care.

Inclusions: 

• Contact research center

Exclusions:

Prior treatment:

Purpose: 

• Collection of blood samples before, during and after treatment to determine if the genetic makeup of the tumor has changed

Basic Qualifications: