Phase 2 Lung Cancer Trial, Recruiting NCT05456256 Sponsor: Lantern Pharma Inc. Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT05456256
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with advanced lung cancer (Stage III or IV) that cannot be removed by surgery, specifically a type called adenocarcinoma, and whose cancer has a specific genetic change that can be targeted by treatment (such as MET exon 14, ALK, EGFR, NTRK, or similar).
  • People whose cancer has either spread to other parts of the body or cannot be removed with surgery.
  • People who have never smoked, or who have smoked fewer than 100 cigarettes (or the equivalent in vapes, cigars, pipes, hookahs, or marijuana) in their entire lifetime. In some cases, people who are former smokers but have a targetable genetic change in their cancer may also be considered, if the trial site's doctors would normally treat them with a specific chemotherapy combination — this would need to be confirmed with the trial sponsor.
  • People whose cancer got worse while taking targeted medicines called tyrosine kinase inhibitors (TKIs), or who had to stop TKIs because of serious side effects.
  • People who have had radiation therapy in the past, as long as there is still at least one area of measurable cancer that was not treated with radiation, and at least 21 days have passed since the radiation finished and side effects have resolved.
  • People who are generally well enough to carry out daily activities with little or no limitation, as rated on a standard medical scale (ECOG score of 0 or 1).
  • People who are at least 18 years old.
  • People who have cancer that has spread to the brain, as long as it has been stable for at least 21 days, is not causing new neurological symptoms, and any seizure medications and steroids have been stopped for at least 14 days before joining.
  • People who have fully recovered from any major surgery related to their cancer, with at least 30 days passed since the operation.
  • People whose blood test results, taken within 21 days before joining, show that their bone marrow, liver, and kidneys are functioning at adequate levels based on specific laboratory measurements (confirm exact values with trial site).
  • Women who could become pregnant must have a negative pregnancy test and agree to use an approved form of contraception during the study and for 12 weeks after the last dose of study treatment (or 6 months if enrolled in South Korea). Men whose partners could become pregnant must also agree to use contraception during the study and for 12 weeks after their last dose.
  • People who have been free of any other cancer for at least two years, except for certain skin cancers, a non-invasive breast condition called DCIS, or non-invasive cervical changes that were successfully treated.
  • People who are willing to provide a stored tumour tissue sample from an area that was not previously treated with radiation, if one is available and was collected within the last 36 months.
  • People who have read and signed an approved consent form before any study tests begin.

Who may not be able to join:

  • People whose lung cancer is a type other than adenocarcinoma, such as small cell, squamous cell, large cell, undifferentiated, mesothelioma, or a mixed type.
  • People whose adenocarcinoma started somewhere else in the body and spread to the lung, rather than starting in the lung itself.
  • People who have previously taken part in other experimental drug trials, except for experimental TKI medicines. A waiting period after stopping any TKI is also required before joining.
  • People whose cancer got worse while they were receiving chemotherapy or immunotherapy (though people who received these treatments and then switched to a TKI without their cancer progressing may still be considered).
  • People who are currently taking certain medications that interact with specific liver enzymes or transport proteins (CYP2C19 or P-gp) — confirm specific medications with the trial site.
  • People who have had a serious heart-related event in the past 6 months, such as heart failure, heart attack, stroke, unstable chest pain, a mini-stroke, or serious irregular heart rhythms.
  • People whose heart's electrical activity shows an abnormally long interval on an ECG (called QTcF greater than 470 milliseconds), unless this is due to a specific known heart condition or a pacemaker, in which case the trial sponsor's medical team would need to be consulted.
  • People who have unstable brain metastases that are causing worsening neurological symptoms or seizures within 21 days before enrolling.
  • People who do not have at least one area of measurable cancer that has not been previously treated with radiation.
  • People who are known to have HIV, hepatitis B, or hepatitis C.
  • People with active infections, active lung inflammation, uncontrolled high blood pressure, uncontrolled diabetes, uncontrolled seizures unrelated to brain metastases within the past 3 months, or other serious health conditions.
  • People who are known to be allergic to any of the study drugs (LP-300, pemetrexed, carboplatin) or their ingredients, or to supportive medications that may be used during the trial.
  • People who are pregnant or breastfeeding.
  • People who have received a blood transfusion within 10 days before joining the trial.
  • People with any other health condition or circumstance that, in the opinion of the study doctor, could affect their ability to follow the study requirements or affect the reliability of the results.
  • People whose doctors estimate they have less than 3 months to live.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Reggie Ewesuedo, MD, Lantern Pharma Inc.

Phone: 832.622.1699

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Lantern Pharma Inc.
Registry
ClinicalTrials.gov
Start date
1 March 2023
Est. completion
1 December 2026

Where this trial is recruiting

🇯🇵 Japan 🇹🇼 Taiwan 🇺🇸 United States

Primary endpoints

Progression-free survival (PFS); Overall survival (OS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov