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Dose Attenuated Chemotherapy in Compromised Patients With Lung Cancer

ConditionsLung CancerSmall-cell Lung CancerNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFox Chase Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carboplatin

    Drug

    Standard of care chemotherapy regimen

  • Pemetrexed

    Drug

    Standard of care chemotherapy regimen

  • Paclitaxel

    Drug

    Standard of care chemotherapy regimen

  • Nab paclitaxel

    Drug

    Standard of care chemotherapy regimen

  • Docetaxel

    Drug

    Standard of care chemotherapy regimen

  • Gemcitabine

    Drug

    Standard of care chemotherapy regimen

  • Etoposide

    Drug

    Standard of care chemotherapy regimen

  • Irinotecan

    Drug

    Standard of care chemotherapy regimen

  • Topotecan

    Drug

    Standard of care chemotherapy regimen

  • Lurbinectedin

    Drug

    Standard of care chemotherapy regimen

Treatment groups

280 Participants
are divided into 3 treatment groups
Group A: Platinum doublet plus immunotherapy (IO)Experimental treatment 10 interventions
Group B: Platinum doublet with or without a VEGFiExperimental treatment 10 interventions
Group C: Single agent chemotherapy with or without a VEGFiExperimental treatment 10 interventions

Trial outcomes

Primary outcomes

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

Time frame
6 years

Secondary outcomes

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).

Time frame
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

Time frame
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.

Time frame
6 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fox Chase Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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