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

Head and Neck: INBRX-105
Sponsor: Inhibrx, Inc.
Study: INBRX-105
Cancer stage: Advanced or Metastatic Solid Tumors

Description: This is a Phase 1 - 2 Study of INBRX-105 and INBRX-105 in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors Inclusions (NCT#03809624)

• Part 2: Patients with head and neck squamous cell carcinoma with locally advanced or metastatic, non-resectable disease, which has progressed despite standard therapy or for whom no standard or clinically acceptable therapy exists.

Exclusions:

• Prior exposure to 4-1BB agonists

Prior treatment:

• Allowed

Purpose:

• This is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab.

• 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: MK3475-867
Sponsor: Merck
Study: Lung: MK3475-867
Cancer stage: Stages I or IIA

Description: A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Medically Inoperable Stages I or IIA NSCLC (KEYNOTE-867) Trial brochure

Inclusions: 

• Has NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA                                                            
• Cannot undergo thoracic surgery due to existing medical illness  
• Is able to receive SBRT
• Has an ECOG Performance Status of 0, 1, or 2

Exclusions: 

• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor                                                                                                                               
• Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast.

Prior treatment: 

• No prior therapy with an anti-PD-1, anti-PD-L1, anti PD-L2 agent or CTLA-4  

Purpose:  

• To compare the Event Free Survival following administration of Stereotactic Body Radiotherapy plus pembrolizumab versus Stereotactic Body Radiotherapy plus placebo  

Basic qualifications:

• Has NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA                                                            
• Cannot undergo thoracic surgery due to existing medical illness  

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: 849-012
Sponsor: Mirati
Study: Lung: 849-012
Cancer stage: Advanced or metastatic disease

Description: A Randomized Phase 3 Study of MRTX849 versus Docetaxel in Patients with Previously Treated Non-Small Cell Lung Cancer with KRAS G12C Mutation. Krystal-7 study flyer

Inclusions: 

• NSCLC with KRAS G12C mutation
• Receipt of prior treatment with a platinum and immune checkpoint inhibitor containing regimen for advanced or metastatic disease

Exclusions: 

• Active brain metastases
• Prior treatment with an agent targeting KRAS G12C

Prior treatment: 

• Prior treatment with an immune checkpoint inhibitor and a platinum containing regimen required

Purpose: 

• To compare the efficacy of MRTX849 versus docetaxel in patients with NSCLC with KRAS G12C mutation

Basic qualifications:

• NSCLC with KRAS G12C mutation 
• Receipt of prior treatment with a platinum containing regimen and an immune checkpoint inhibitor

Lung: BGB-317-A1217-302
Sponsor: BeiGene
Study: Lung: BGB-317-A1217-302
Cancer stage: Previously untreated locally advanced unresectable or metastatic Non-Small Cell Lung Cancer

Description: A Phase 3, Randomized, Double-Blind Study of BGB-A1217, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non -Small Cell Lung Cancer

Inclusions: 

• NSCLC that is not eligibel for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy
• No prior systemic treatment for metastatic NSCLC
• Tumors with PD-L1 expression as centrally determined
• Measurable lesions

Exclusions: 

• Known senstizing mutation in the EGFR gene or an ALK fusion oncogene
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis

Prior treatment: 

• No prior systemic treatment for metastatic NSCLC

Purpose: 

• This study compares progression-free survival and overall survival between arm A (BGB-A1217 in combination with Tislelizumab) and arm B (Pembrolizumab followed by placebo)

Basic qualifications:

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

WST-PZP-005 for peripheral neuropathy
Sponsor: Winsantor
Study: WST-PZP-005
Cancer stage: Stage 3 or 4

Description: A randomized, double-blind, placebo-controlled, phase 2a study of topical Pirenzepine (WST-057) or placebo for the prevention of dose limiting chemotherapy induced peripheral neuropathy in oncology patients administered Carboplatin and Paclitaxel.

Inclusions: 

• Patients scheduled to undergo chemotherapy for an advanced or metastatic (stage 3 or 4) solid tumor with carboplatin and paclitaxel for 6 cycles of treatment.

Exclusions: 

• Pre-existing history of peripheral neuropathy due to any cause other than prior chemotherapy

Prior treatment: 

• Allowed

Purpose: 

• Evaluate the efficacy of once-daily topical dosing of WST-057 by assessing intrasubject change from baseline in function using the patient reported outcomes- FACT/GOG-Ntx 13, neurotoxicity subscale and the PROMIS Physical Function Score.

Basic qualifications: 

• Patients starting treatment with Carboplatin and Paclitaxel