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-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

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

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

AbbVie M20-621
Sponsor: AbbVie
Study: M20-621
Cancer Stage: Lymphoma (DLBCL)

Description: A Phase 3, Randomized, Open-Label Study to Evaluate Change in Disease Activity of Epcoritamab Combined With Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (R-CHOP) or R-CHOP alone in Adult Participants With Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL)

Inclusions:

• Newly diagnosed, histologically confirmed CD20+ DLBCL
• Measurable disease
• IPI score of 2-5

Exclusions:

• Prior treatment

Prior treatment:

• Not allowed

Purpose:

• To Evaluate Safety and Efficacy of Epcoritamab

Basic qualifications:

• See inclusions

AbbVie M20-638
Sponsor: AbbVie
Study: M20-638
Cancer Stage: Relapsed or Refractory

Description: Phase 3, Open-Label Study to Evaluate Safety and Efficacy of Epcoritamab in Combination with Rituximab and Lenalidomide (R2) compared to R2 in Subjects with Relapsed or Refractory Follicular Lymphoma (EPCORE™ FL-1) (NCT#05409066)

Inclusions:

• Histologically confirmed classic Follicular Lymphoma(previously Grade 1 to 3a FL) stage II, III, or IV
• At least 1 prior treatment with an antiCD20 monoclonal antibody in combo with chemotherapy
• Measurable disease

Exclusions:

• Evidence of histologic transformation to an aggressive lymphoma
• Current evidence of primary central nervous system (CNS) lymphoma
• Clinically significant cardiovascular disease or liver disease

Prior treatment:

• Yes
  

Purpose: 

• To Evaluate Safety and Efficacy of Epcoritamab in combination with R2 compared to R2 alone

Basic Qualifications: 

• See inclusions

Lung: A151216 (ALCHEMIST Screen)
Sponsor: Alliance
Study: Lung: A151216 (ALCHEMIST Screen)
Cancer stage: Resectable NSCLC IB-IIIA

Description:

Inclusions:

• For post-surgical patients
• Completely resected non-small cell lung cancer. Patients with squamous cell carcinoma are eligible.
• Pathologic stage IIIA, II or IB (defined as size ≥4 cm) For all patients • ECOG Performance Status 0-1 • Age ≥ 18 years
• No prior or concurrent malignancies within 5 years, except non-melanoma skin carcinoma or in situ carcinomas. A secondary primary lung cancer is considered a concurrent malignancy and would make a patient ineligible for A151216.• No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD-1/PD-L1/CTLA-4.
• Patients who have had local genotyping are eligible, regardless of the local result.
• No patients with recurrence of lung cancer after prior resection. Patient Registration Eligibility Criteria
• Pathologic stage IIIA, II, or large IB (defined as size ≥ 4cm)
• Tissue available for the required analyses (either clinical tissue block or slides and scrolls)
• In order to allow for time for central genotyping and eligibility for the ALCHEMIST treatment trial, patients must register within the following eligibility windows, depending on the adjuvant treatment approach:

1. If no adjuvant therapy, register patient within 75 days following surgery.
2. If adjuvant chemotherapy only, register patient within 225 days following surgery.
3. If adjuvant chemotherapy and radiation, register patient within 285 days following surgery.

Exclusions:

Prior treatment:

• No patients who have received neoadjuvant therapy (chemo- or radio-therapy) for this lung cancer.

Purpose:

• This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been removed or will be removed by surgery.

Basic qualifications:

• Completely resected (resectable) non-small cell lung cancer.
• Patients with squamous cell carcinoma are eligible.

Lung: JZP712-402
Sponsor: Jazz Pharmaceuticals
Study: Lung: JZP712-402
Cancer stage: Extensive Stage Small Cell Lung Cancer

Description: Phase IV Observational Study to Collect Safety and Outcome Data in Adult Patients with Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Zepzelca

Inclusions:

• Patient has initiated or will be receiving Zepzelca treatment in line with the Zepzelca US prescribing information

Exclusions:

• Patients who discontinued a prior Zepzelca treatment due to adverse events

Prior treatment:

Purpose:

• This is a phase IV observational study designed to collect data on treatment with Zepzelca

Basic qualifications:

• The treatment decision, decision to initiate Zepzelca, and overall patient management is entirely at the investigators’ discretion and should not be impacted by the conduct of this study

Lung: E4512 (ALCHEMIST - ALK)
Sponsor: ECOG-ACRIN
Study: Lung: E4512 (ALCHEMIST - ALK)
Cancer stage: Resectable NSCLC IB-IIIA

Description:

Inclusions:

• Age ≥ 18 years.
• Patients must have undergone complete surgical resection of their stage IB (≥ 4 cm), II, or non-squamous IIIA NSCLC and have had negative margins. N3 disease is not allowed.
• ECOG performance status 0 or 1.
• Positive for translocation or inversion events involving the ALK gene locus (e.g. resulting in EML4-ALK fusion) as determined by the Vysis Break Point FISH assay and defined by an increase in the distance between 5’ and 3’ ALK probes or the loss of the 5’ probe.
• No known interstitial fibrosis or interstitial lung disease.
• No use of medications, herbals, or foods that are known potent CYP3A4 inhibitors or inducers.
• Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinomas and non-melanoma skin cancer.

Exclusions:

Prior treatment:

• Adjuvant treatment is allowed. No prior treatment with crizotinib or another ALK inhibitor.

Purpose:

• This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.

Basic qualifications:

• Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A151216) trial prior to randomization.

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

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:

Lung: AbbVie M18-868
Sponsor: AbbVie
Study: M18-868
Cancer Stage: Lung (NSCLC)

Description: A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Inclusions:

• non-squamous cell NSCLC that is locally advanced or metastatic
• C-Met overexpression

Exclusions:

• Participants who have received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin

Prior treatment:

• Allowed

Purpose:

• The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated

Basic Qualifications:

• non-squamous cell NSCLC that is locally advanced or metastatic
• C-Met overexpression

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

NOUS-209-01 for Solid Tumors
Sponsor: Nouscom
Study: NOUS-209-01
Cancer Stage: Unresectable or metastatic gastric or GE junction tumors

Description: A Phase I/II, Multicenter, Open-Label Study of Nous-209 Genetic Vaccine for the Treatment of Microsatellite Unstable Solid Tumors in combination with Pembrolizumab

Inclusions:

• Proven microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) status
• Subjects with locally advanced unresectable or metastatic MSI-H/ dMMR CRC who have had radiographic progression (PD) after having a best response of stable disease (SD) or better on/after anti-PD1 treatment
• May have progressed on additional approved therapy

Exclusions:

• Known active central nervous system (CNS) metastases

Prior treatment:

• Allowed

Purpose:

• To evaluate safety, tolerability, and efficacy of NOUS-209-01 genetic vaccine

Basic Qualifications:

• Subjects with locally advanced unresectable or metastatic, microsatellite instability high (MSI-H) or dMMR CRC who are eligible for anti-PD-1 1st line of treatment or who have progressed after having stable disease or better on/after anti-PD1 treatment

Aadi TSC-007 for solid tumors
Sponsor: Aadi Bioscience
Study: TSC-007
Cancer Stage: Metastatic, locally advanced, or non-resectable solid tumors

Description: Phase 2 basket trial of nab-sirolimus in patients with malignant solid tumors with pathogenic alterations in TSC1/TSC2 Genes.

Inclusions:

• Patients must have received all standard therapies appropriate for tumor type and stage of disease
• Measurable disease
• inoperable
• ECOG 0-1

Exclusions:

• Prior treatment with an mTOR inhibitor, including nab-sirolimus
• Primary brain tumors or PEComa

Prior treatment:

• Allowed

Purpose:

• To determine the efficacy and safety profile of nab-sirolimus administered to patients with malignant solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes.

Basic Qualifications:

• See inclusions

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