Featured Clinical Trials

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.
   

Phone: 855-907-3286

The purpose of the study is to compare the efficacy and safety of BMS-986489 (anti-fucosyl-GM1+ nivolumab fixed-dose combination) in combination with carboplatin plus etoposide to that of atezolizumab with carboplatin plus etoposide as first-line therapy in adult participants with extensive-stage small cell lung cancer.

Who can participate?

• Participants must be healthy enough to do their normal activities with little or no help based on the ECOG performance scale.
• Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system.

Those interested should contact the participating site nearest them for more details. A list of sites is located on the trial's ct.gov listing.

About the trial:

S1900K: A Randomized Phase II Study of Tepotinib with or without Ramucirumab in Participants with MET Exon 14 Skipping Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

The trial is set up to find out if treating people with both tepotinib and ramucirumab — instead of only tepotinib — can lower the chance that the cancer will grow or spread. It's also testing whether this drug combination can lower the chance that people will develop swelling in their arms and legs as a side effect from tepotinib.

Who can participate:

This study is open to patients who were diagnosed with stage IV non-small cell lung cancer (NSCLC). It tests treatment for people whose NSCLC has a MET exon 14 skipping gene change (alteration). The study is not for people were already treated with:
•       Tepotinib or other drugs that target MET gene changes
•       Ramucirumab or similar drugs
 

Those interested should contact the participating site nearest them for more details. A list of sites is located on the trial's ct.gov listing.

About the trial:

S1900J: A Phase II Study of Amivantamab SC (Subcutaneous) in Participants with MET Amplification-Positive Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

The trial is set up to find out if a drug called amivantamab SC can shrink the cancer and lower the chance that the cancer will grow or spread. Everyone in the trial will receive amivantamab SC.

Who can participate:

This study is open to patients who were diagnosed with stage IV non-small cell lung cancer (NSCLC). It tests treatment for people with NSCLC that has extra copies of the MET gene (MET amplification). The study is specifically for people whose cancer got worse after earlier treatment — but not for people who have already received a drug that targets the MET gene (like tepotinib, capmatinib, or crizotinib).

Those interested should contact the participating site nearest them for more details. A list of sites is located on the trial's ct.gov listing.

About the trial:

S1900G: A Randomized Phase II Study of Capmatinib (Tabrecta) plus Osimertinib (Tagrisso) with or without Ramucirumab (Cyramza) in Participants with EGFR-Mutant, MET-Amplified Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Sub-Study)

The trial is set up to find out if adding the drug ramucirumab to 2 other drugs — osimertinib and capmatinib — lowers the chance that the cancer will spread or get worse. Osimertinib targets EGFR gene changes, capmatinib targets MET gene changes, and ramucirumab blocks tumors from forming new blood vessels (pathways that carry blood to the tumors).

Who can participate:

This study is open to patients who were diagnosed with stage IV non-small cell lung cancer. It tests targeted treatments for people with advanced non-small cell lung cancer that has certain changes (mutations) in both the EGFR and MET genes. The study is specifically for people whose cancer got worse after they took osimertinib.