NRG-BR009
Sponsor: NRG
Study: NRG-BR009
Cancer Stage: Any

Description: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score (NCT#05879926)

Inclusions:

• Patients must be premenopausal (evidence of functioning ovaries)
• patients who meet eligibility based on a “Low Risk” or “MP1” result on MammaPrint® testing must have an Oncotype DX Recurrence Score® assay done
• Patient may have undergone a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy no more than 16 weeks prior
• tumor must be ER and/or PgR-positive, HER2-negative based on local testing results

Exclusions:

• Metastatic disease
• pT4 tumors, including inflammatory breast cancer
• History of ipsilateral or contralateral invasive breast cancer

Prior treatment: 

• Prior chemotherapy, radiation, or biotherapy not allowed

Purpose: 

• To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Basic Qualifications: 

• See inclusion/exclusion criteria

NRG-BR009 Brochure

NRG-BR008
Sponsor: NRG
Study: NRG-BR008
Cancer Stage: Any

Description: A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO*) *Her2 Radiation Optimization (HERO) (NCT#05705401)

Inclusions:

• Invasive breast carcinoma HER2-positive
• female and male patients over the age of 40 who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy
• Must have undergone axillary staging, either sentinel node biopsy (SNB) or axillary lymph nodal dissection (ALND)

Exclusions:

• Metastatic disease
• Pathologically positive axillary nodes at any time
• Patient planning for or status-post mastectomy
• Non-epithelial breast malignancies such as sarcoma or lymphoma

Prior treatment: 

• Required

Purpose: 

• To compare the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the current standard of care.

Basic Qualifications: 

• See inclusion/exclusion criteria

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

Arcus ARC-25
Sponsor: ARCUS Biosciences, Inc.
Study: ARC-25
Cancer Stage: Advanced malignancies

Description: A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB598 Monotherapy and Combination Therapy in Participants with Advanced Malignancies

Inclusions:

• Measurable disease
• Vary per cohort

Exclusions:

• Prior treatment with a therapeutic targeting CD39

Prior treatment:

• Varies with cohort

Purpose:

• The primary purpose of this study is to assess the safety and tolerability of AB598 when taken alone, and in combination with zimberelimab and standard chemotherapy in participants with advanced malignancies.

Basic qualifications:

• See inclusions

ARC-25 Participant brochure

High risk of Ovarian Cancer Surgical Study: NRG-CC008
Sponsor: NRG Oncology
Study: Ovarian Cancer Risk: NRG- CC008
Cancer stage: None

Description: A study to compare two surgical procedures in women with BRCA1 mutations to assess reduced risk of Ovarian Cancer

Inclusions:

• Women 35-50 years of age, inclusive
• At least one intact ovary and fallopian tube

Exclusions:

• A history of any prior cancer and received chemotherapy within the past 12 months
• hormonal therapy in the past 90 days
• or radiotherapy to abdomen or pelvis at any prior time

Prior treatment:

• No prior treatment within the past 12 months

Purpose:

• A study to compare two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) in women with BRCA1 mutations to assess reduced risk of Ovarian Cancer

Basic qualifications:

• Women 35-50 years of age with a high risk of ovarian cancer with at least one intact ovary and fallopian tube undergoing surgery

Gynecologic: NRG-GY019
Sponsor: NRG Oncology
Study: GY019
Cancer stage: Stage II-IV

Description: A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum (NCT#04095364)

Inclusions:

• Newly diagnosed Stage II-IV ovarian cancer
• Must have undergone an attempt at maximal upfront cytoreductive surgery and bilateral salpingo-oophorectomy

Exclusions:

• May not have received neoadjuvant chemotherapy or radiotherapy and no previous hormonal therapy for the treatment of this disease

Prior treatment:

• None

Purpose:

• To examine if letrozole monotherapy/maintenance (L/L) is non-inferior to IV paclitaxel/carboplatin and maintenance letrozole (CT/L) with respect to PFS in women with stage II-IV primary low-grade serous carcinoma of the ovary or peritoneum after primary surgical cytoreduction.

Basic qualifications:

• Same as inclusion criteria

Gynecologic: NRG-GY026
Sponsor: NRG Oncology
Study: GY026
Cancer Stage: Stage I-IV Endometrial Carcinoma or Carcinosarcoma

Description: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with Either Trastuzumab and Hyaluronidase-oysk (HERCEPTIN HYLECTA) or Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf (PHESGO) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma (NCT#05256225)

Inclusions:

• Stage IA-IVB, non-recurrent, chemo-naïve, HER2-positive endometrial serous carcinoma or endometrial carcinosarcoma.

Exclusions:

• Prior chemotherapy, biologic therapy, or targeted therapy for endometrial cancer (prior hormonal therapy allowed)
• Prior radiation for endometrial cancer

Prior treatment:

• Prior chemotherapy or radiation not allowed

Purpose: 

• To evaluate the efficacy of trastuzumab and hyaluronidase-oysk (HERCEPTIN HYLECTA) and pertuzumab, trastuzumab, and hyaluronidase-zzxf (PHESGO) in combination with paclitaxel/carboplatin in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.

Basic qualifications: 

• Same as inclusion criteria

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

NEOD001-301 (AFFIRM)
Sponsor: Prothena
Study: NEOD001-301
Cancer stage: Newly diagnosed

Description: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis

Inclusions:

• Newly diagnosed and AL amyloidosis treatment naive
• Bone marrow demonstrating clonal plasma cells
• Confirmed diagnosis of AL amyloidosis

Exclusions:

• Non-AL amyloidosis
• Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma, except for malignancy biomarker of involved/uninvolved serum free light chain ratio ≥100

Prior treatment:

• No

Purpose:

• To evaluate the efficacy of birtamimab

Basic qualifications:

• See inclusions

AFFIRM-AL-Study guide reference cards

Lung: 849-007
Sponsor: Mirati
Study: Lung: 849-007
Cancer stage: Metastatic or unresectable NSCLC

Description: Krystal-7 study flyer

Inclusions:

• NSCLC (squamous or nonsquamous) with KRAS G12C mutation
• Unresectable or metastatic disease
• Not a candidate for chemoradiation for locally advanced disease

Exclusions:

• Prior systemic treatment for locally advanced or metastatic NSCLC

Prior treatment:

• No prior treatment allowed

Purpose:

• To evaluate the clinical activity of the MRTX849 study drug in combination with pembrolizumab administered in the first-line treatment setting to patients having NSCLC with KRAS G12C mutation

Basic qualifications:

• NSCLC (squamous or nonsquamous) with KRAS G12C mutation
• Unresectable or metastatic disease

Lung: NRG-CC009 for Small Cell Lung Cancer (SCLC) with Brain Mets
Sponsor: NRG
Study: NRG-CC009
Cancer Stage: Brain Mets

Description: Trial of Stereotactic Radiosurgery (SRS) versus Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) for 10 or fewer Brain Metastases from Small Cell Lung Cancer

Inclusions:

• Ten or fewer brain metastases

Exclusions:

• Intractable seizures while on adequate anticonvulsant therapy; more than 1 seizure per month for the past 2 months
• Current use of (other NMDA antagonists) amantadine, ketamine, or dextromethorphan
• Prior radiotherapy to the brain, including SRS, WBRT, or PCI

Prior treatment:

• Allowed

Purpose:

• To 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

Basic Qualifications:

• Patient with SCLC with 10 or fewer brain metastases

NRG-GU011
Sponsor: NRG Oncology
Study: GU011
Cancer Stage: advanced stage

Description: A Phase II Double-Blinded, Placebo-Controlled Trial of Prostate Oligometastatic Radiotherapy with or Without Androgen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean) (NCT# 05053152)

Inclusions:

• Diagnosis of prostate adenocarcinoma at any anatomical location
• ECOG Performance Status 0-2
• Prior curative-intent treatment by external beam and/or brachytherapy or radical prostatectomy
• 1-5 oligometastatic lesions in bone and/or nodal/soft tissue sites

Exclusions:

• Can not currently be on androgen deprivation or anti-androgen therapy

Prior treatment:

• None

Purpose: 

• To Compare conventional radiological progression-free survival (rPFS) for positron emission tomography (PET)-detected, biochemically recurrent, oligometastatic, castration-sensitive prostate cancer patients treated with SABR plus placebo vs. SABR plus relugolix

Basic Qualifications: 

• Same as inclusion criteria

NRG-GU013 High Five

Sponsor: NRG Oncology
Study: GU013
Cancer Stage: High risk disease

Description: A Phase III trial for high-risk prostate cancer

Inclusions:

• Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
• ECOG Performance Status 0-2

Exclusions:

• Metastatic disease outside of the pelvic nodes

Prior treatment:

• No prior radiotherapy to the region of cancer
• No prior radical prostatectomy
• Prior pharmacologic androgen ablation for prostate cancer is allowed if ≤ 185 days prior

Purpose: 

• To compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultra hypofractionation (SBRT) to those randomized to moderate hypofractionation and conventional fractionation.

Basic Qualifications:

• Same as inclusion criteria

Amgen 20210023 for solid tumors
Sponsor: Amgen
Study: 20210023
Cancer Stage: Metastatic, locally advanced, or not amenable to curative treatment with surgery and/or radiation MTAP-null solid tumors

Description: A phase 1/1b/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 193 alone and in combination with docetaxel.

Inclusions:

• Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) (Parts 1a, 1j, 1k, and 2a only) and/or methylthioadenosine phosphorylase (MTAP) (null) in the tumor tissue or blood (Parts 1a to 1k, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1k, Parts 2a and 2b)
• Measurable disease
• ECOG 0-1

Exclusions:

• Untreated brain metastases
• Myocardial infarction and/or CHF
• Prior treatment with docetaxel (Part 2 only)
• Prior irradiation to 25% of the bone marrow

Prior treatment:

• Allowed

Purpose:

• To evaluate safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel

Basic Qualifications:

• See inclusions

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