Featured Clinical Trials

Genmab Trial Information, Email: [email protected]

About the trial:

Phase 3, Prospective, Open Label, Randomized Trial of Acasunlimab (GEN1046) in Combination with Pembrolizumab Versus Docetaxel in Subjects with PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment with a PD-1/PD-L1 Inhibitor and Platinum-Containing Chemotherapy

This is a phase 3 clinical trial designed to evaluate the safety and efficacy of an investigational treatment, acasunlimab, in combination with pembrolizumab compared to the standard chemotherapy drug docetaxel in patients with metastatic non-small cell lung cancer.

Acasunlimab is an investigational treatment called a “bispecific antibody,” a type of immunotherapy. Bispecific antibodies can bind to two different targets at the same time. Acasunlimab is designed to target two proteins, PD-L1 and 4-1BB, aiming to stimulate the immune system to fight cancer.

During the study, participants will be assigned to receive either acasunlimab and pembrolizumab by IV (intravenous) once every 6 weeks or docetaxel by IV once every 3 weeks.

Who can participate:

• Must have lung cancer that has metastasized (spread)
• Have tumors that are positive for the PD-L1 protein (a biomarker that may be predictive of response to therapy)
• Will have been previously treated with a PD-1/PD-L1-inhibitor and a platinum-containing cancer therapy administered in combination or sequentially

For comprehensive eligibility, please reach out to a participating provider

 

Brandee Colter, Local Trial Manager, [email protected]

The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with chemotherapy versus participants who receive pembrolizumab with chemotherapy. 

Who can participate:

Patients must have a confirmed KRAS G12C mutation, which occurs in ~13% of NSCLC patients, and the tumor must be PD-L1 negative.

Myisha Prudhomme, [email protected]

About the trial:

LN-145 is a ready-to-infuse TIL therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI and further optimized by Iovance for the treatment of patients with metastatic NSCLC. The cell transfer therapy used in this study involves patients receiving a non-myeloablative (NMA) lymphodepleting preparative regimen, followed by infusion of autologous TIL, then finally followed by the administration of IL-2.

Who can participate:

Inclusion criteria:

• Patients who are over 70 years of age may be allowed to enroll after discussion with the Medical Monitor.
• Have historically or pathologically confirmed diagnosis of metastatic stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations.
• For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted therapy is required.
• Patients must have documented radiographic disease progression on or after the first-line therapy, including concurrent or sequential ICI and platinum-based chemotherapy ± bevacizumab. No more than 1 prior line is allowed if ICI and platinum-based chemotherapy were administered concurrently and no more than 2 prior lines are allowed for sequential administration of platinum-based chemotherapy and ICI as 2 separate lines.
• LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the front-line ICI and platinum-based chemotherapy combination and meet all eligibility criteria except documented disease progression. These patients must intend to receive TIL therapy after disease progression. Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part of definitive chemoradiotherapy, will count as a line of therapy if the patient had disease progression during or within 12 months after the completion of such therapy.
• At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1
• Have adequate organ function LVEF > 45%, NYHA Class 1
• Have adequate pulmonary function
• ECOG performance status of 0 or 1
• Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy

Exclusion criteria:

• Patients who have EGFR, ALK or ROS1 driver mutations
• Patients who have symptomatic, untreated brain metastases
• Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years
• Patients who have any form of primary immunodeficiency
• Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent
• Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
• Patients who have had another primary malignancy within the previous 3 years
• Participation in another interventional clinical study within 21 days

Please see the list of participating sites in the clinicaltrials.gov posting to contact a participating provider near you.

About the trial:

An Open-label, Randomized Study of BMS-986489 (Atigotatug + Nivolumab Fixed-dose Combination) vs Durvalumab as Consolidation Therapy Following Chemoradiotherapy in Limited-stage Small-cell Lung Cancer (TIGOS-LS)

This is an open-label, randomized study of BMS-986489 (atigotatug + nivolumab fixed-dose combination) vs durvalumab as consolidation therapy following chemoradiotherapy in participants with limited-stage (LS)-small-cell lung cancer (SCLC). Participants will receive concurrent chemotherapy and radiotherapy according to standard guidelines for treatment of LS-SCLC without progressive disease prior to randomization.

Who can participate:

People who meet the following criteria are eligible to participate in this clinical trial:

• At least 18 years of age
• ECOG performance of 0 or 1
• Confirmed SCLC, via RECIST v1.1
• LS disease as determined by PET scan prior to chemo/radiation
• Completed chemo/radiation without progression per RECIST within 42 days prior to randomization
• PCI (if applicable) after chemo and complete 14-42 days before randomization
• Adequate hematologic and organ function
• Willingness to abide by protocol contraceptive requirements for duration of study 

For comprehensive eligibility please reach out to a participating provider.
 

[email protected]

LISCA-Lung1 is a clinical trial that is exploring whether an investigational medication called alisertib is effective in treating patients with pathologically confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and an anti-PD-L1 immunotherapy agent. 

Who can participate?

• Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy.
• Eligible patients must be at least 18 years old and cannot have used an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib, in any setting.
• There are additional inclusion and exclusion criteria.  The investigator at the study center will determine if you meet all of the criteria.