90 Participants Needed

LP-300 + Chemotherapy for Lung Adenocarcinoma EGFR

(HARMONIC Trial)

Recruiting at 25 trial locations
DB
BM
EK
SE
Overseen BySelin Ergulen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, LP-300, combined with two existing chemotherapy drugs in never smokers with a specific type of lung cancer who did not respond to previous treatments. The goal is to see if this combination improves survival by making the chemotherapy more effective.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but it does mention a 'washout period' for tyrosine kinase inhibitors (TKIs) of at least 5 half-lives or 2 weeks, whichever is shorter. Also, you cannot take medications that are sensitive substrates of CYP2C19 or P-gp transporters.

What data supports the effectiveness of the drug combination LP-300, Carboplatin, and Pemetrexed for lung adenocarcinoma?

Research shows that Pemetrexed, when combined with Carboplatin, has demonstrated antitumor activity and mild toxicity in treating non-small cell lung cancer, which is a type of lung cancer similar to lung adenocarcinoma.12345

Is the combination of LP-300 and chemotherapy safe for humans?

Pemetrexed, a drug used in combination with carboplatin for lung cancer, has been shown to have mild side effects when patients take folic acid and vitamin B12 supplements. Common side effects include fatigue, nausea, and vomiting, but these are generally manageable.36789

What makes the LP-300 + Chemotherapy drug unique for lung adenocarcinoma?

The LP-300 + Chemotherapy treatment is unique because it combines LP-300, a novel agent, with carboplatin and pemetrexed, which are standard chemotherapy drugs. LP-300 is designed to enhance the effectiveness of chemotherapy by potentially reducing toxicity and improving outcomes, offering a new approach compared to traditional chemotherapy regimens.810111213

Research Team

RE

Reggie Ewesuedo, MD

Principal Investigator

Lantern Pharma Inc.

Eligibility Criteria

This trial is for never smokers over 18 with advanced lung adenocarcinoma, including those who've had TKI treatment but now show disease progression or can't tolerate TKIs. Participants must have stable CNS metastases, adequate organ function, and no recent serious cardiovascular events. They should not be HIV or hepatitis positive and must agree to use contraception.

Inclusion Criteria

Have you been diagnosed with Stage 3 or Stage 4 non-small cell lung cancer?
Has your disease progressed despite treatment?
Have you ever been a smoker?
See 18 more

Exclusion Criteria

Have you ever been a smoker?
I do not have any active infections, lung issues, uncontrolled high blood pressure, diabetes, seizures, or other serious health problems.
Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

6 patients are enrolled and treated with LP-300 in combination with carboplatin and pemetrexed to assess safety

3 weeks
1 visit (in-person) per cycle

Treatment

Patients are randomized to receive either the investigational arm of LP-300 with carboplatin and pemetrexed or the standard of care arm of carboplatin and pemetrexed. Treatment occurs on Day 1 of a 21-day cycle for 4 to 6 cycles.

12-18 weeks
1 visit (in-person) per cycle

Maintenance

Patients may enter a pemetrexed maintenance phase after the initial treatment cycles

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Carboplatin
  • LP-300
  • Pemetrexed
Trial OverviewThe study tests the effectiveness of LP-300 combined with carboplatin and pemetrexed chemotherapy in improving survival without cancer progression compared to just chemotherapy alone. It's an open-label phase II trial involving 90 patients across multiple U.S. centers.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: LP-300 in Combination with Pemetrexed and CarboplatinExperimental Treatment3 Interventions
LP-300 (investigational drug) + Pemetrexed and Carboplatin (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.
Group II: Pemetrexed and Carboplatin (Standard of Care)Active Control2 Interventions
Pemetrexed and Carboplatin Only (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Paraplatin for:
  • Ovarian cancer
  • Testicular cancer
  • Lung cancer
  • Head and neck cancer
  • Brain cancer
🇪🇺
Approved in European Union as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
🇨🇦
Approved in Canada as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
  • Testicular cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lantern Pharma Inc.

Lead Sponsor

Trials
4
Recruited
390+

Findings from Research

Pemetrexed is an effective treatment for relapsed or chemotherapy-refractory non-small cell lung cancer (NSCLC), showing similar response and survival rates to taxotere but with less toxicity.
When combined with platinum analogs or other chemotherapy agents like gemcitabine or vinorelbine, pemetrexed produces equivalent responses and overall survival outcomes, suggesting it is a viable option in NSCLC treatment regimens.
Role of pemetrexed in non-small cell lung cancer.Longo-Sorbello, GS., Chen, B., Budak-Alpdogan, T., et al.[2022]
In a study of 53 patients with advanced non-small cell lung cancer (NSCLC) who had previously undergone platinum-based chemotherapy, treatment with pemetrexed plus cisplatin or carboplatin resulted in a median overall survival of 10 months and a median progression-free survival of 6 months.
The treatment was generally well-tolerated, with only a small percentage of patients experiencing severe side effects, such as grade 3 or 4 leukopenia and thrombocytopenia, indicating that pemetrexed combined with platinum-based drugs can be a safe option for these patients.
Pemetrexed plus cisplatin/carboplatin in previously treated locally advanced or metastatic non-small cell lung cancer patients.Zhang, GZ., Jiao, SC., Meng, ZT.[2021]
Pemetrexed, when combined with carboplatin, has shown promising antitumor activity with mild toxicity in phase II clinical trials, but it can lead to serious adverse reactions such as toxic epidermal necrolysis, as seen in a reported case.
Supplementation with folic acid and vitamin B12 is recommended during pemetrexed treatment to help reduce the risk of hematological and gastrointestinal side effects, although severe skin reactions can still occur.
Toxic epidermal necrolysis related to pemetrexed and carboplatin with vitamin B12 and folic acid supplementation for advanced non-small cell lung cancer.Bosch-Barrera, J., Gaztañaga, M., Ceballos, J., et al.[2015]

References

Role of pemetrexed in non-small cell lung cancer. [2022]
Pemetrexed plus cisplatin/carboplatin in previously treated locally advanced or metastatic non-small cell lung cancer patients. [2021]
Toxic epidermal necrolysis related to pemetrexed and carboplatin with vitamin B12 and folic acid supplementation for advanced non-small cell lung cancer. [2015]
Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. [2023]
Pemetrexed (Alimta): a new antifolate for non-small-cell lung cancer. [2017]
FDA drug approval summaries: pemetrexed (Alimta). [2022]
Pemetrexed in advanced NSCLC: a review of the clinical data. [2015]
Pembrolizumab plus pemetrexed-carboplatin combination in first-line treatment of advanced non-squamous non-small cell lung cancer: a multicenter real-life study (CAP29). [2023]
Pemetrexed plus carboplatin or cisplatin as neoadjuvant treatment of operable malignant pleural mesothelioma (MPM). [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Paclitaxel/carboplatin in the treatment of non-small-cell lung cancer. [2015]
Carboplatin and paclitaxel for previously treated patients with non-small-cell lung cancer. [2019]
A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Paclitaxel plus carboplatin for advanced lung cancer: preliminary results of a Vanderbilt University phase II trial--LUN-46. [2015]