carboplatin for Non-Small Cell Lung Carcinoma (NSCLC)

Phase-Based Estimates
1
Effectiveness
1
Safety
Seattle Cancer Care Alliance, Seattle, WA
+27 More
carboplatin - Drug
Eligibility
18+
All Sexes
Eligible conditions
Non-Small Cell Lung Carcinoma (NSCLC)

Study Summary

(HARMONY) Study of BLU-701 in EGFR-mutant NSCLC

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Eligible Conditions

  • Thoracic Neoplasms
  • Neoplasms, Nerve Tissue
  • Lung Cancer
  • Neoplasms by Histologic Type
  • Lung Diseases
  • Adenocarcinoma
  • Respiratory Tract Neoplasms
  • Carcinoma, Bronchogenic
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasms by Site
  • Respiratory Tract Diseases
  • Carcinoma
  • Cancer
  • Bronchial Neoplasms
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • EGFR Activating Mutation
  • EGFR C797A
  • EGFR C797G
  • Lung Neoplasms
  • EGFR L858R
  • EGFR C797S
  • Protein Kinase Inhibitors
  • EGFR Exon 19 Deletion
  • Neoplasms, Lung
  • Neoplasms
  • Antineoplastic Agents
  • EGFR C797X
  • EGFR Gene Mutations
  • EGFR Mutation Resulting in Tyrosine Kinase Inhibitor Resistance
  • EGF-R Positive Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether carboplatin will improve 4 primary outcomes and 13 secondary outcomes in patients with Non-Small Cell Lung Carcinoma (NSCLC). Measurement will happen over the course of Up to 12 months.

Up to 12 months
[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-701 monotherapy, BLU-701 in combination with osimertinib, and BLU-701 in combination with platinum-based chemotherapy
[Phase 1] Determine the recommended Phase 2 dose (RP2D) of BLU-701 monotherapy, BLU-701 in combination with osimertinib, and BLU-701 in combination with platinum-based chemotherapy
[Phase 1] Overall response rate (ORR)
[Phase 1] Overall safety profile
Up to 30 months
[Phase 2] Overall response rate (ORR)
Up to 42 months
[Phase 1 and Phase 2] Duration of response (DOR)
[Phase 1 and Phase 2] To characterize the PK profile of BLU-701
[Phase 1] To assess treatment-induced modulation of EGFR pathway biomarkers for BLU-701 monotherapy
[Phase 2] Central Nervous System Duration of Response (CNS-DOR)
[Phase 2] Central Nervous System Overall Response Rate (CNS-ORR)
[Phase 2] Central Nervous System Progression Rate
[Phase 2] Clinical Benefit Rate (CBR)
[Phase 2] Overall Survival (OS)
[Phase 2] Overall safety profile
[Phase 2] Progression Free Survival (PFS)
[Phase 2] To assess the effect of BLU-701 on cardiovascular intervals, including QT, and rhythm
[Phase 2]Disease Control Rate (DCR)

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

No Control Group
Part 1B: BLU-701 with osimertinib

This trial requires 160 total participants across 4 different treatment groups

This trial involves 4 different treatments. Carboplatin is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Part 1B: BLU-701 with osimertinibBLU-701 in combination with osimertinib 40 mg or 80 mg tablets for oral administration
Part 1C: BLU-701 with platinum-based chemotherapyBLU-701 in combination with platinum-based chemotherapy (carboplatin and pemetrexed): Carboplatin - IV infusion dosed to target AUC of 5-6 mg/mL min q3w Pemetrexed - IV infusion dosed to 500 mg/m2 q3w
Part 2A: BLU-701 as monotherapy
Drug
Phase 2 expansion group for BLU-701 as monotherapy at a dose determined during Part 1A in patients harboring the EGFR C797X resistance mutation
Part 1A: BLU-701 as monotherapy
Drug
Phase 1 dose escalation of BLU-701 as monotherapy at various dose levels
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Osimertinib
FDA approved
Pemetrexed
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 42 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 42 months for reporting.

Closest Location

Seattle Cancer Care Alliance - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
≥18 years of age at the time of signing the informed consent.
Pathologically confirmed metastatic NSCLC.
Tumor mutation profile determined locally via next generation sequencing (NGS), using tumor tissue (preferably from a progressing lesion) and/or ctDNA in plasma. For Phase 1, it is preferable that samples used for analysis be obtained during or after disease progression on the last EGFR-targeted TKI received. For Phase 2, samples used for analysis must be obtained during or after disease progression on the last EGFR-targeted TKI received.
You have EGFR mutation (Ex19Del or L858R). show original
Tumor must harbor an EGFR C797X resistance mutation. show original
Part 1A and 2A: At least 1 prior third-generation EGFR-targeted TKI, such as osimertinib
Part 1B: Patients must have experienced progressive disease while on osimertinib, were able to tolerate prior osimertinib 80 mg QD dose, and continuing on osimertinib is deemed to be in the patient's best interests in the opinion of the Investigator.
Patients who have discontinued osimertinib may be eligible, if no more than 6 weeks elapse between the discontinuation of prior osimertinib and resumption of osimertinib on study.
Part 1C: At least 1 prior EGFR-targeted TKI
Willing to provide pretreatment tumor sample (either an archival sample or a sample obtained by pretreatment biopsy. For Phase 1, it is preferable that pretreatment tumor sample be obtained from a progressing lesion and during or after disease progression on the last EGFR-targeted TKI received. For Phase 2, pretreatment tumor sample must be obtained during or after disease progression on the last EGFR-targeted TKI treatment received. Patients without appropriate archival tissue available, where biopsy is not considered safe and/or medically feasible, may be discussed with the study medical monitor and approved for enrollment on a case-by-case basis.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is carboplatin safe for people?

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Carboplatin was well tolerated in this group of people with advanced NSCLC. The majority of people in the study were able to tolerate the drug. Side effects were manageable and included mild diarrhoea, vomiting, rash, fatigue, sleep disturbances, and constipation. Based on these data, carboplatin appears to be a reasonable option for people with advanced NSCLC receiving first line chemotherapy.

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Is carboplatin typically used in combination with any other treatments?

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Carboplatin therapy was combined with all other treatments In a recent study except radiation. Although there is no proof that carboplatin may be combined safely with radiotherapy, it is still recommended as part of standard chemotherapy regimens because of its effectiveness.

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Can neoplasms by histologic type be cured?

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Regardless of the histologic type, it is possible to cure neoplasms by surgical excision alone if appropriate therapy is administered; therefore, curative surgery is recommended for all neoplasms, regardless of histologic type.

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What is the primary cause of neoplasms by histologic type?

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It was suggested that breast cancer arose as a result of genetic changes which caused the stem cells in the mammary glands to become more susceptible to environmental carcinogens. The alterations in the gene expression profile were probably due to the accumulation of mutations during tumorigenesis.

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What is the average age someone gets neoplasms by histologic type?

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There is no single age at onset of neoplasms, but there is a trend of earlier onset with increasing malignancy. This pattern is consistent across all histologic types except adenocarcinoma.

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How serious can neoplasms by histologic type be?

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The high mortality associated with stage III rectal cancer and strong association between stage II and mortality of colon cancers suggest that patients must be considered seriously when considering surgery. It may be advisable to consider chemotherapy if possible and to discuss the decision with the patient before surgery. If surgery is planned, it should be performed only for curative motives.

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What are the signs of neoplasms by histologic type?

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A number of signs and symptoms can help identify a specific neoplasm based on its histology. These include color, size, shape, symmetry, and irregularity of the tumor. Other signs and symptoms can also be helpful, such as rapid growth rate, location of the tumor, and presence of metastatic disease.

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What are the common side effects of carboplatin?

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The most common side effects of carboplatin were nausea (25%), fatigue (20%), diarrhea (18%), vomiting (17%), and anemia (<10%). Other less common side effects included constipation (>5%), rash (>4%), headache (<4%), cough (<4%), and pneumonitis (<4%). Most common toxicities occurred on days 4–12 after the first infusion of carboplatin. The incidence and severity of these adverse effects increased with higher doses and shorter infusion times.

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What causes neoplasms by histologic type?

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Neoplasms by histological type occur throughout the body and not just in humans. The most common tumors are carcinomas (both squamous and nonsquamous) and lymphomas. They are not found very often in children. There are some cases of nonmelanoma skin cancers being more common in African Americans than Caucasians. Neurogenic tumors tend to be less common than other types. There are no significant differences in frequency of occurrence of neuroendocrine tumors according to race. [power(https://www.withpower.com/clinical-trials/neoplasms-by-histological-type) maybe helpful as you search for appropriate clinical trials.

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What are the latest developments in carboplatin for therapeutic use?

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Carboplatin is used extensively in metastatic ovarian carcinoma. The combination with paclitaxel has been shown to be active in patients with recurrent disease. It seems likely that further study of the use of carboplatin alone or combined with other agents such as paclitaxel, topotecan, or gemcitabine may reveal a role for this drug in the treatment of ovarian carcinoma.

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What does carboplatin usually treat?

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The chemotherapy drugs used in metastatic bladder cancer often include carboplatin (Gemzar), paclitaxel (Taxol), vinorelbine (Elvograf), bacillus Calmette-Guérin (BCG), and methotrexate, as well as some other agents. This article discusses these drugs' usual indications and side effects, as well as possible interactions between the drugs. In the case of BCC, the discussion focuses on the role of cisplatin and cyclophosphamide as well as newer agents such as gemcitabine, mitomycin C, and ifosfamide.

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