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Adenocarcinoma of LungPhase 2HARMONICNCT05456256

A Study of LP-300 With Carboplatin and Pemetrexed in Never Smokers With Advanced Lung Adenocarcinoma

A Phase 2 study testing LP-300, Pemetrexed and Carboplatin in people with Adenocarcinoma of Lung and Carcinoma, Non-Small-Cell Lung, run by Lantern Pharma Inc. at 16 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LP-300, Pemetrexed and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
16 sitesin 3 countries
Study dates
1 Mar 2023to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Prior radiation therapy is allowed, provided (1) that at least one area of measurable tumor (by computed tomography (CT) scan with at least one target lesion) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 that has not been subject to prior irradiation, and (2) that any such therapy is completed and any radiation-induced sequelae are recovered at least 21 days before randomization.
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Patients who are at least 18 years of age.
  • Patients with documented stable central nervous system (CNS) metastases with no cognitive deficits, or progressive sensory or motor deficits, or seizures during the last 21 days prior to enrollment are eligible. Patients must have discontinued anti-seizure medications and steroids at least 14 days prior to patient enrollment.
  • Patients must have fully recovered from any prior major surgical or diagnostic staging procedure (e.g., thoracotomy, mediastinoscopy), and have a post-operative status of at least 30 days before enrollment.
  • Patients must have adequate bone marrow, adequate hepatic function, and baseline creatinine levels documented by specific laboratory criteria within 21 days prior to enrollment, including the following:
  • White blood cell count ≥ 2 x 10*9/L
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10*9/L
  • Hemoglobin ≥ 10 g/dL
  • Platelet count ≥ 100 x 10*9/L
  • Total bilirubin < 1.5 x the upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin < 2.5 x ULN
  • Aspartate aminotransferase/ serum glutamic oxaloacetic transaminase (AST/SGOT) ≤ 2.5 x ULN
  • Alanine aminotransferase/ serum glutamic pyruvic transaminase (ALT/SGPT) ≤ 2.5 x ULN
  • Alkaline phosphatase ≤ 2.5 x ULN
  • Baseline serum creatinine level no greater than 1.5 mg/dL or 133 μmol/L.
  • Creatinine clearance ≥ 45 mL/min as calculated using the Cockcroft-Gault methodology (Cockcroft 1976)
  • Magnesium ≥ 1.7 mg/dL
  • Female patients of child-bearing potential must have a negative pregnancy test and must agree to use an acceptable contraceptive method during the study and for 12 weeks after their last dose of study treatment. Male patients with partners of child-bearing potential must also agree to use an adequate method of contraception for the duration of the study and for 12 weeks after their last dose of study treatment.
  • Note: a) A patient is considered of childbearing potential if she is biologically capable of having children and is sexually active. Medically acceptable contraceptives include: (1) surgical sterilization (such as a tubal ligation, hysterectomy, or vasectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide (only if used in combination with another mentioned method), or (4) an intrauterine device (IUD). Contraceptive measures and other medications sold for emergency use after unprotected sex, are not acceptable methods for routine use. If a female patient becomes pregnant, study therapy must be discontinued immediately. Lastly, b) the period for use of contraception after last dose of pemetrexed or carboplatin should be determined by the domestic drug labels and/or institutional standard clinical practice. For S Korea, contraception is to be used for 6 months after the last dose.
  • Patients must have been disease-free at least two years for other malignancies, excluding:
  • Curatively-treated basal cell carcinoma,
  • Ductal carcinoma in situ (DCIS) of the breast
  • Non-melanomatous carcinoma of the skin, or
  • Carcinoma in situ of the cervix.
  • Be willing to provide an archival tumor tissue sample, if available. The archival sample must be from a tumor lesion that was not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. The sample must have been obtained less than 36 months prior to consent.
  • Provide signed, written, Institutional Review Board (IRB) approved informed consent prior to any screening procedures.

Who cannot join

  • 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.
  • Patients taking medications that are sensitive substrates of CYP2C19 or P-gp transporters
  • Patients with recent onset (within 6 months of randomization) of congestive heart failure (New York Heart Association Classification Class II or greater), angina pectoris, unstable angina pectoris, serious uncontrolled cardiac arrhythmias, myocardial infarction, stroke, or transient ischemic attacks.
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  • Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of > 470 msec. (average of triplicate ECGs) at Screening and/or on C1D1 (pre- dose) except for a documented bundle branch block or unless secondary to pacemaker. In the case of a documented bundle branch block or a pacemaker, discussion with the Medical Monitor is required prior to enrollment.
  • Patients with unstable CNS metastases (characterized by progressive sensory/motor impairment, cognitive/speech impairment, or seizure activity) within 21 days before enrollment.
  • Patients who do not have at least one (1) measurable disease site that has not been previously irradiated.
  • Patients who are known to be positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HbsAg) or hepatitis C virus (HCV).
  • Patients with active infections, active interstitial lung disease, uncontrolled high blood pressure, uncontrolled diabetes mellitus, uncontrolled seizures (not due to CNS metastases) within the last 3 months, or other serious underlying medical condition.
  • Patients with documented hypersensitivity to any of the study medications (LP-300, pemetrexed, carboplatin and/or excipients) or supportive agents that may be used.
  • Patients who are pregnant or are breastfeeding.
  • Patients who have undergone blood transfusions within 10 days before randomization.
  • 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.
  • Patients who have a life expectancy of less than 3 months.

Trial locations and contacts

16 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Sandra Sinclair contact

832.622.1699

sandra@lanternpharma.com

16 sites in 3 countries

United States6 sites, 5 recruiting

  • Precision NextGen Oncology and Research Center

    Beverly Hills, California, 90212

    Mini Gill, minig@nextgenonc.com

    Kamalesh Sankhala, MD

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

    Adam Itani, 214-645-1365, adam.itani@utsouthwestern.edu

    Jonathan Dowell, MD

    Recruiting

  • Inova Fairfax Hospital

    Fairfax, Virginia, 22031

    Mahwish Bari, Mahwish.Bari@inova.org

    Janakiraman Subramanian, MD

    Recruiting

  • Los Angeles Cancer Network

    Fountain Valley, California, 92708

    Elizabeth Brown, Elizabeth.Brown@lahomg.com

    Eric Lee, MD

    Recruiting

  • Cancer and Blood Specialists Clinic

    Los Alamitos, California, 90720

    Suspended

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Taylor Branch, Taylor.Branch@fccc.edu

    Joseph Treat, MD

    Recruiting

Other trials in United States

Japan5 sites

  • National Cancer Center Hospital

    Chuo-ku, Tokyo

    Active, not recruiting

  • Okayama University Hospital

    Okayama, Okayama-ken

    Active, not recruiting

  • Hokkaido Cancer Center

    Sapporo, Hokkaido

    Active, not recruiting

  • Tohoku University Hospital

    Sendai, Miyagi

    Active, not recruiting

  • Kanagawa Cancer Center Hospital

    Yokohama, Kanagawa

    Active, not recruiting

Other trials in Japan

Taiwan5 sites, 5 recruiting

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu

    Hui-Chen Yang, isan2383@yahoo.com.tw

    Yueh-Feng Wen, MD

    Recruiting

  • Chi Mei Medical Center

    Tainan

    Summer Liu, summer700622@gmail.com

    Chao-Hsun Chen, MD

    Recruiting

  • National Cheng Kung University Hospital

    Tainan

    Man-Yui Lai, dicky941221@gmail.com

    Chun-Hui Lee, MD

    Recruiting

  • Taipei Veterans General Hospital

    Taipei

    Yun Huang, huangyun0117@gmail.com

    Yung-Hong Luo, MD

    Recruiting

  • TriService General Hospital-Neihu Main Facility

    Taipei

    Ya-Chi Liu, hotcgin0067@gmail.com

    Shan-Yueh Chang, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: Phase II Trial of LP-300 in Combination With Carboplatin and Pemetrexed in Never Smoker Patients With Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment With Tyrosine Kinase Inhibitors (The HARMONIC Study)

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.

Read the detailed description

Patients who are never smokers with lung adenocarcinoma and have relapsed after treatment with tyrosine kinase inhibitors (TKIs) will be eligible for enrollment. The trial will proceed in two stages. In the safety lead-in stage, 6 patients will be enrolled and treated with the LP-300 co-administered in combination with carboplatin and pemetrexed. In the absence of any safety signals in these patients, the second stage of the trial protocol will begin. This second stage consists of randomizing patients in a 2:1 allocation ratio to one of two arms: investigational arm of carboplatin, pemetrexed, and LP-300 or the standard of care arm of carboplatin and pemetrexed. Treatment of both groups will be on Day 1 of a 21-day cycle. A total of 4 to 6 treatment cycles are planned (number of cycles determined by PI discretion), with the possibility of patients going into a pemetrexed maintenance phase afterwards.

Being tested
LP-300, Pemetrexed, Carboplatin
Keywords
never smoker, non smoker, EGFR, ALK, ROS, MET, tyrosine kinase inhibitor, TKI, pemetrexed, carboplatin, NSCLC, never-smoker, non-smoker, TK inhibitor, lung cancer
Medical subject headings
Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LP-300Drug

    Also called Tavocept, BNP7787, Dimesna

    LP-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.

  • PemetrexedDrug

    Also called Alimta, Pemfexy

    Pemetrexed: 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.

  • CarboplatinDrug

    Also called Paraplatin

    Carboplatin: 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.

Study groups in NCT05456256
Study groupRoleWhat they receive
LP-300 in Combination with Pemetrexed and CarboplatinExperimentalLP-300 (investigational drug) + Pemetrexed and Carboplatin (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.
Receives: Drug: LP-300; Drug: Pemetrexed; Drug: Carboplatin
Pemetrexed and Carboplatin (Standard of Care)Active comparatorPemetrexed and Carboplatin Only (standard of care chemotherapies) Dosing occurs on Day 1 of a 21-day cycle.
Receives: Drug: Pemetrexed; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Through study completion, an average of 2 years

  2. Overall survival (OS)

    Number of days or months between the randomization date and the date of death from all causes

    Measured: Through study completion, an average of 2 years

Secondary outcomes (4)

  1. Objective response rate (ORR)

    Proportion of patients with the best overall response of complete response or partial response

    Measured: Through study completion, an average of 2 years

  2. 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

    Measured: Through study completion, an average of 2 years

  3. 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

    Measured: Through study completion, an average of 2 years

  4. 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).

    Measured: From initiation of study treatment to 30-days after the last dose of study drug.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start1 Mar 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05456256
Sponsor's protocol ID
LTRN300-2LC01-OR21
Acronym
HARMONIC
Status last verified
Apr 2026
First submitted
6 Jul 2022
Last updated
4 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LP-300, Pemetrexed and Carboplatin in people with Adenocarcinoma of Lung and Carcinoma, Non-Small-Cell Lung, run by Lantern Pharma Inc. at 16 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States, Japan, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sandra Sinclair (832.622.1699, sandra@lanternpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05456256.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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