A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLantern Pharma Inc.
About this trial
The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population. The primary objectives of this study are to determine progression-free survival (PFS) and overall survival (OS) in the study-defined patient population when LP-300 is co-administered with the standard of care chemotherapy drugs carboplatin and pemetrexed compared to carboplatin and pemetrexed alone. This has been designed as a multicenter, open label, phase II trial with 90 patients to be enrolled in the United States.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with confirmed histopathological diagnosis of inoperable advanced (Stage III or IV) primary adenocarcinoma (including bronchioalveolar cell carcinoma) of the lung with specific actionable genomic alterations (e.g., mesenchymal epithelial transition (MET) exon14 skipping mutations, anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), neurotrophic tyrosine receptor kinase (NTRK) fusions, etc.). If pathological or radiological findings are inconclusive for a diagnosis of primary adenocarcinoma of the lung, additional studies must be performed to confirm primary lung versus metastatic adenocarcinoma. Patients with no known actionable genomic alterations are ineligible to enroll in the study.
Locally advanced inoperable or metastatic lung cancer.
Patients must be never smokers: a never smoker is an adult who has never smoked, or who has smoked less than 100 cigarettes (or equivalent in other products such as vapes, cigars, pipes, hookahs, and marijuana use) in his or her lifetime. Note: a patient with actionable genomic alteration(s) who is a former smoker may be enrolled if such a patient would ordinarily be treated with pemetrexed and carboplatin combination based on institutional standard clinical practice; consultation with the sponsor's Medical monitor would be required
Patients who have received systemic treatment with tyrosine kinase inhibitors (TKIs) for non-small cell lung cancer but have experienced disease progression, unacceptable TKI-related toxicities, or are unable to tolerate the further use of TKIs.
Disqualifiers
Patients with small cell, squamous cell, large cell, undifferentiated, mesothelioma, or any form of mixed (e.g., small cell and adenocarcinoma or squamous and adenocarcinoma) histopathological diagnosis of primary lung cancer.
Patients with metastatic adenocarcinoma arising from any primary site other than the lung.
Patients who have received any prior investigational agents except for investigational TKI drugs. The minimum drug washout period for all TKIs, including approved and investigational, is ≥ 5 half-lives or 2 weeks, whichever is shorter.
Patients who have received chemotherapy and/or immunotherapy but transitioned to a TKI with no evidence of disease progression will be allowed to enroll. Patients who experienced disease progression while on chemotherapy and/or immunotherapy will be ineligible for the trial.
Trial design
Design model
Parallel
Treatments tested in this trial
LP-300
DrugLP-300: 18.4 g/m2 by intravenous (IV) infusion over 30 minutes, administered every 21 days for a total of 4 to 6 treatment cycles. The number of treatment cycles will be determined by PI discretion.
Pemetrexed
DrugPemetrexed: 500 mg/m2 by intravenous (IV) infusion over 30 minutes, administered every 21 days for a total of 4 to 6 treatment cycles. After completion of the 4 to 6 cycles, patients will have the option to continue pemetrexed maintenance therapy until disease progression, unacceptable toxicity, or patient preference/physician discretion. The number of treatment cycles will be determined by PI discretion.
Carboplatin
DrugCarboplatin: area under the concentration-time curve 5 mg/mL per minute (AUC5) by intravenous (IV) infusion over 30 minutes, administered every 21 days for a total of 4 to 6 treatment cycles. The number of treatment cycles will be determined by PI discretion.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: LP-300 in Combination with Pemetrexed and CarboplatinExperimental treatment 3 interventions
Group B: Pemetrexed and Carboplatin (Standard of Care)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS)
Number of days or months from the date of randomization to the earliest of the documented disease progression based on the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria
Time frame
Through study completion, an average of 2 years2
Overall survival (OS)
Number of days or months between the randomization date and the date of death from all causes
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
Objective response rate (ORR)
Proportion of patients with the best overall response of complete response or partial response
Time frame
Through study completion, an average of 2 years2
Duration of objective response (DOR)
Time when the complete response/partial response criteria are met (whichever is first recorded) until the first date that recurrent or progressive disease is documented
Time frame
Through study completion, an average of 2 years3
Clinical benefit rate (CBR)
Proportion of patients with the best overall response of complete response or partial response or stable disease for at least 120 days
Time frame
Through study completion, an average of 2 years4
Safety of LP-300 in combination with pemetrexed and carboplatin
Incidence and severity of adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, and changes in clinical laboratory parameters, vital signs and electrocardiograms (ECGs).
Time frame
From initiation of study treatment to 30-days after the last dose of study drug.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov