AzTrials
AzTrials

Lung CancerPhase 2NCT05800587

Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

A Phase 2 study testing Carboplatin, Pemetrexed and Paclitaxel in people with Lung Cancer and Small-cell Lung Cancer, run by Fox Chase Cancer Center at 1 site in United States.

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

This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Carboplatin, Pemetrexed and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteUnited States
Study dates
22 Feb 2023to 1 Aug 2029
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

  • Must have histologically or cytologically confirmed stage IV (AJCC version 8) lung cancer (small cell or non-small cell). Patients with stage III disease who are not felt to be candidates for definitive therapy are also eligible.
  • Must fit into at least one of the subgroups of patients as defined in section 3.3.
  • Patients must have planned therapy with a regimen that includes at least one cytotoxic agent as listed in Table 1 (e.g. platinum, taxane, anti-metabolite, vinca alkaloid, podophylotoxin, camptothecin, lurbinectidin etc).
  • Must have measurable disease as per RECIST criteria 1.1.
  • History of treated or untreated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
  • No ongoing requirement for corticosteroids as therapy for CNS disease
Show all 15Show fewer
  • No stereotactic radiation or whole-brain radiation within 7 days prior to treatment initiation
  • Stable doses of anti-seizure medications are allowed if CNS disease has been treated and is stable. Treatment of CNS disease can include surgery, radiation or response to prior systemic therapy.
  • May have received prior therapy for lung cancer. There is no limit on the number of prior therapies.
  • Age > 18 years
  • ECOG performance status of 0-3
  • Ability to understand and willingness to sign a written informed and HIPAA consent documents.
  • Females of child-bearing potential must be willing to use an effective method of contraception for the course of the study through at least 6 months after the last dose of study medication.
  • Patients with known HIV infection and are receiving combination antiretroviral therapy with a viral load <400 copies per mL at screening or CD4+ T-cell count > 350 cell per μL at screening and no history of AIDS-defining opportunistic infection < 12 months before first dose of study drug are eligible.
  • Males who are fertile and who have partners who are Women of Child-bearing Potential (WOCBP) must agree to use effective method(s) of contraception as outlined in section 4.4 from the start of trial treatment, for the course of the study and 6 months after the last dose of study treatment.

Who cannot join

  • Patients receiving only a targeted agent (e.g. TKI, sotorasib etc.) or immunotherapy without a cytotoxic agent.
  • Patients currently receiving investigational agents for cancer.
  • Patients with ECOG PS 3 and hepatic or renal dysfunction.
  • Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.
  • Undergone major surgery within 28 days prior to first dose of study treatment. The patient has elective or planned major surgery to be performed during the course of the clinical trial.
  • Have not recovered from adverse events due to anticancer agents administered previously except neuropathy, alopecia or endocrinopathies that can be treated with replacement therapy. Physician's discretion is allowed to decide which unresolved adverse events from previous therapy prohibit patient participation in this study.
Show all 13Show fewer
  • Uncontrolled illness including, but not limited to, ongoing or active infection (other than chronic viral infections that are controlled, e.g. HIV, as described above), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia (uncontrolled), cirrhosis, or psychiatric illness/ social situations that would limit compliance with the study requirements.
  • Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Leptomeningeal disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Indwelling catheters (e.g., PleurX®) are allowed.
  • Corrected serum Ca > 12 mg/dl.
  • Patients who are receiving hypocalcemic therapies (e.g. denosumab, bisphosphonates) who achieve appropriate serum calcium levels are eligible.
  • Pregnant or breast feeding.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ryan Romasko contact

2678388380

ryan.romasko@fccc.edu

United States1 site, 1 recruiting

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

    Ryan Romasko, 267-838-8380, ryan.romasko@fccc.edu

    Julia Judd, DO

    Recruiting

Other trials in United States

About this study

Official title: Phase II Study of Dose Attenuated Chemotherapy in Patients With Lung Cancer and Age > 70 and/or Comorbidities

This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities.

Read the detailed description

This is an open-label, non-randomized, single-center, phase II study to evaluate the efficacy, toxicity and, tolerability of pre-specified dose attenuated chemotherapy regimens in lung cancer patients with comorbidities. The investigator will indicate the rationale(s) for dose modification based on the subgroups of patients listed in the protocol. Patients may fit into multiple subgroups and this is accounted for in the prospectively defined dose reduction level as listed in the protocol. Prespecified doses by chemotherapeutic agent and dose level adjustment based on patient characteristics and comorbidities are listed in the protocol. Analyses will be stratified by treatment group 1-3 based on the treating physician's selected therapy.

Medical subject headings
Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • CarboplatinDrug

    Standard of care chemotherapy regimen

  • PemetrexedDrug

    Standard of care chemotherapy regimen

  • PaclitaxelDrug

    Standard of care chemotherapy regimen

  • Nab paclitaxelDrug

    Standard of care chemotherapy regimen

  • DocetaxelDrug

    Standard of care chemotherapy regimen

  • GemcitabineDrug

    Standard of care chemotherapy regimen

  • EtoposideDrug

    Standard of care chemotherapy regimen

  • IrinotecanDrug

    Standard of care chemotherapy regimen

  • TopotecanDrug

    Standard of care chemotherapy regimen

  • LurbinectedinDrug

    Standard of care chemotherapy regimen

Study groups in NCT05800587
Study groupRoleWhat they receive
Platinum doublet plus immunotherapy (IO)ExperimentalNot described
Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Docetaxel; Drug: Gemcitabine; Drug: Etoposide; Drug: Irinotecan; Drug: Topotecan; Drug: Lurbinectedin
Platinum doublet with or without a VEGFiExperimentalNot described
Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Docetaxel; Drug: Gemcitabine; Drug: Etoposide; Drug: Irinotecan; Drug: Topotecan; Drug: Lurbinectedin
Single agent chemotherapy with or without a VEGFiExperimentalNot described
Receives: Drug: Carboplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Docetaxel; Drug: Gemcitabine; Drug: Etoposide; Drug: Irinotecan; Drug: Topotecan; Drug: Lurbinectedin

What is being measured

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

  1. Objective response rate (ORR)

    To estimate the ORR including confirmed complete response (CR) and partial response (PR) rates in each treatment group 1-3

    Measured: 6 years

Secondary outcomes (3)

  1. Frequency of adverse events

    To evaluate the frequency and severity of toxicities attributed to chemotherapy administered on trial. To evaluate the tolerability of prospectively dose attenuated chemotherapy

    Evaluate toxicity by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 criteria (CTCAE 5.0) by Treatment Group in all patients who received at least one dose of treatment on trial.

    Tolerability will be defined as receiving two or more chemotherapy cycles with no more than a one week delay (due to treatment related toxicity) during the initial treatment period (first four cycles), delivered with pre-specified dose modifications to the cytotoxic component(s) of standard regimens for NSCLC and SCLC. Proportions of adverse events will be tabulated and organized by grade (all grade and grade 3 or higher).

    Measured: 6 years

  2. Progression free survival (PFS)

    To evaluate PFS in each treatment group. PFS is defined as the time from treatment initiation until documented disease progression, clinical progression, death, or the end of follow-up, whichever occurs first. Patients who are still alive and progression free at last follow-up will be considered censored at the time of last tumor assessment

    Measured: 6 years

  3. Overall survival (OS)

    To evaluate overall survival (OS) in each treatment group. OS is defined as the time from treatment initiation until death. Patients who are still alive at end of follow-up will be considered censored.

    Measured: 6 years

Timeline

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

  1. First posted5 Apr 2023
  2. Study start22 Feb 2023
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Aug 2029 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05800587
Sponsor's protocol ID
22-1052
Other IDs
TH-214
Status last verified
May 2026
First submitted
24 Mar 2023
Last updated
22 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 Carboplatin, Pemetrexed and Paclitaxel in people with Lung Cancer and Small-cell Lung Cancer, run by Fox Chase Cancer Center at 1 site in United States.

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 15 inclusion and 13 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 22 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 1 site in United States. 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 Ryan Romasko (2678388380, ryan.romasko@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 6 years). 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 NCT05800587.

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 22 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in