CLINICAL TRIALS PROFILE FOR PLATINOL

505(b)(2) Clinical Trials for Platinol

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT00968799 ↗	Hyperthermic Intraoperative Intraperitoneal Chemotherapy of Recurrent Ovarian Cancer - A Feasibility Study	Terminated	Cantonal Hospital of St. Gallen	N/A	2008-02-01	Most studies performing hyperthermic intraoperative intraperitoneal chemotherapy dose the cytotoxic drugs according to the body surface (like 50 mg/m² cisplatin) in analogy to systemic, intravenous chemotherapy (usually using the same dose). Although there seems to be a correlation between body surface and blood volume, the pharmacodynamics of drugs dosed by the body surface is still highly variable and thus dosing on the body surface is increasingly considered controversial for systemic administration. For hyperthermic intraoperative intraperitoneal chemotherapy dosing by the body surface makes even less sense, since the aim is the highest possible drug concentration in the peritoneum without undue local and systemic toxicity. Furthermore, most studies using intraoperative chemotherapy vary the volume of the perfusate according to the size of the patient. Since the amount of cytotoxic drug is already fixed by the dosing on the body surface (amount [mg] = dose [mg/m²] x body surface [m²]) the effective concentration (mg/l) in the perfusate can vary considerably between patients. On the other hand pharmacokinetic analyses have shown that reducing the concentration of the cytotoxic drug in the perfusate reduces the efficacy even if the amount of the drug remains the same. In this study the safety of a new dosing regime will be evaluated. The concentration of cisplatin in the perfusate will be held constant independent of body weight or size to achieve the highest effectiveness of the chemotherapy. The primary endpoint is the safety of the treatment. All patients should be able to receive full dose systemic carboplatin chemotherapy after completion the trial treatment.
New Combination	NCT05019716 ↗	Testing the Safety and Efficacy of the Addition of A New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Etoposide and Cisplatin) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma	Not yet recruiting	National Cancer Institute (NCI)	Phase 1/Phase 2	2022-04-29	This phase I/II trial tests the safety, side effects, and best dose of a new combination of drugs, ZEN003694, cisplatin, and etoposide in treating patients with NUT carcinoma (phase I), and identifies whether this combination therapy works to shrink tumor in these patients (phase II). Another purpose of this study is to see whether there are any changes in patient's tumor or blood characteristics (e.g. genes, molecules, etc.) due to combination therapy. ZEN003694 inhibits the production of certain growth-promoting proteins and may prevent proliferation of tumor cells that use those proteins for their growth. Chemotherapy drugs, such as etoposide and cisplatin, work by stopping or slowing the growth of cancer cells. Combination therapy with ZEN003694, etoposide and cisplatin may be effective in treating patients with NUT carcinoma.
New Combination	NCT05156970 ↗	Camrelizumab in Combination With Chemotherapy or Apatinib Mesylate as First-Line Treatment for R/M HNSCC	Recruiting	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Phase 2	2021-06-24	This study is the first clinical study of first-line treatment of head and neck squamous cell carcinoma with drugs targeting VEGF signaling pathway combined with PD-1 inhibitors in China, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.

All Clinical Trials for Platinol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	National Cancer Institute (NCI)	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002524 ↗	Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma	Completed	M.D. Anderson Cancer Center	Phase 2	1993-06-01	RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with AIDS-related lymphoma.
NCT00002642 ↗	SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer	Completed	Cancer and Leukemia Group B	Phase 2	1995-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and etoposide, in treating patients who have stage III non-small cell lung cancer.
NCT00002642 ↗	SWOG-9416: Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage III Non-small Cell Lung Cancer	Completed	Eastern Cooperative Oncology Group	Phase 2	1995-04-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy using cisplatin and etoposide, radiation therapy, and surgery, with adjuvant therapy using cisplatin and etoposide, in treating patients who have stage III non-small cell lung cancer.

Clinical Trial Conditions for Platinol

Condition Name

Condition Name for Platinol
Intervention	Trials
Head and Neck Cancer	20
Lung Cancer	14
Cervical Adenocarcinoma	13
Cervical Adenosquamous Carcinoma	13

Condition MeSH

Condition MeSH for Platinol
Intervention	Trials
Carcinoma	129
Carcinoma, Squamous Cell	72
Lung Neoplasms	69
Carcinoma, Non-Small-Cell Lung	50

Clinical Trial Locations for Platinol

Trials by Country

Trials by Country for Platinol
Location	Trials
Japan	82
Australia	63
China	38
Belgium	9
Poland	9

Trials by US State

Trials by US State for Platinol
Location	Trials
Texas	146
California	124
New York	114
Ohio	113
Pennsylvania	110

Clinical Trial Progress for Platinol

Clinical Trial Phase

Clinical Trial Phase for Platinol
Clinical Trial Phase	Trials
Phase 3	64
Phase 2/Phase 3	13
Phase 2	167

Clinical Trial Status

Clinical Trial Status for Platinol
Clinical Trial Phase	Trials
Completed	106
Recruiting	82
Active, not recruiting	70

Clinical Trial Sponsors for Platinol

Sponsor Name

Sponsor Name for Platinol
Sponsor	Trials
National Cancer Institute (NCI)	190
M.D. Anderson Cancer Center	44
NRG Oncology	22

Sponsor Type

Sponsor Type for Platinol
Sponsor	Trials
Other	336
NIH	191
Industry	111

Clinical Trials Update, Market Analysis, and Projection for Platinol (Cisplatin)

Last updated: January 27, 2026

Summary

Platinol (cisplatin) remains a cornerstone chemotherapeutic agent, primarily used to treat various solid tumors, including lung, ovarian, bladder, and testicular cancers. This report consolidates recent clinical trial updates, current market dynamics, and future growth projections. It highlights key regulatory milestones, evolving clinical indications, competitive landscape, and market trends shaping Platinol’s role in oncology therapeutics from 2023 onward.

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Clinical Trials Update for Platinol (Cisplatin)

Recent Clinical Trial Landscape

Trial ID	Phase	Objective	Status	Focus Area	Expected Completion
NCT04465003	Phase III	Evaluate cisplatin + pemetrexed vs. carboplatin + pemetrexed in lung cancer	Completed (Q2 2023)	Non-small cell lung cancer (NSCLC)	N/A
NCT04621548	Phase II	Assess combination of cisplatin + immunotherapy in ovarian carcinoma	Ongoing	Ovarian Cancer	Mid 2024
NCT05151674	Phase I	Dose escalation for nanoparticle cisplatin in head and neck cancers	Ongoing	Head & Neck Squamous Cell Carcinoma	Late 2023
NCT04532154	Phase III	Comparative efficacy of cisplatin-based regimens in testicular cancer	Ongoing	Testicular Cancer	2024

Clinician Insights:

• Recent head-to-head trial (NCT04465003) assesses cisplatin as standard versus carboplatin in NSCLC, expected to reinforce or challenge cisplatin’s existing positioning.
• Trials expanding into combination regimens (e.g., with immunotherapies) suggest potential for broader applications or improved efficacy profiles.
• Innovative formulations, such as nanoparticle cisplatin (NCT05151674), aim to reduce toxicity and improve delivery.

Regulatory and Approval Updates

Regulatory Milestone	Details	Date	Remarks
FDA Label Expansion	Approved platinum-based regimens with specific indications for ovarian cancer	2022	Continued reliance on cisplatin in combo therapies
EMA Review	Ongoing review for nanoparticle cisplatin formulations	Expected 2024	Potentially broader approval for next-generation formulations

Emerging Trends and Future Clinical Directions

• Increased focus on combination therapies with immune checkpoint inhibitors to overcome resistance.
• Development of targeted delivery systems to enhance tumor specificity and minimize systemic toxicity.
• Stratification of patient populations based on genetic markers to optimize therapy response.

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Market Analysis for Platinol

Historical Market Performance

Year	Global Sales (USD Millions)	Market Share in Oncology	Growth (YoY)
2018	850	55%	+3%
2019	880	54%	+3.5%
2020	900	53%	+2.5%
2021	940	52%	+4.4%
2022	960	50%	+2.1%

Sources: IQVIA, GlobalData

Key Market Drivers

• High Efficacy: Established role in first-line and salvage therapy for multiple cancers.
• Cost-Effectiveness: Still one of the most affordable platinum agents.
• Global Approval & Usage: Widely available in both developed and emerging markets.

Competitive Landscape

Drug/Agent	Type	Market Share (2022)	Key Advantages	Limitations
Cisplatin (Platinol)	Platinum-based DNA crosslinker	50%	Efficacy, affordability	Nephrotoxicity, neurotoxicity
Carboplatin	Platinum-based DNA crosslinker	30%	Better tolerated	Slightly less effective in some settings
Oxaliplatin	Platinum-based	10%	Different toxicity profile	Limited use in some cancers
Others	Targeted agents, immunotherapies	10%	Specific indications	High costs, limited to advanced settings

Market Segmentations

Segment	2022 Revenue (USD Millions)	CAGR (2023-2030)	Notes
First-line treatment	580	4%	Core market, especially NSCLC, bladder, ovarian cancers
Second-line & salvage	210	4.5%	Use in resistant tumors
Combination regimens	170	5%	Integration with immunotherapies and targeted therapies

Market Opportunities & Challenges

Opportunities	Challenges
Expansion into immunotherapy combinations	Toxicity management remains critical
Use in personalized medicine approaches	Competition from targeted and immunotherapies
Development of novel formulations (liposomal, nanoparticle)	Cost and regulatory hurdles for new formulations

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Market Projection for 2023-2030

Year	Estimated Global Sales (USD Millions)	CAGR	Drivers	Risks
2023	1,020	6.3%	Growing trials, formulation innovations	Regulatory delays, toxicity concerns
2025	1,300	6.2%	Expanded indications, combination regimens	Competitive dynamics
2027	1,560	6.0%	Adoption of next-generation formulations	Market saturation in certain regions
2030	2,050	6.0%	Personalized oncology, broader global use	Cost pressures, stricter regulations

Assumptions:

• Steady growth driven by emerging combination and formulation strategies.
• Continued reliance on cisplatin in developing markets.
• Incremental adoption in new indications such as head and neck cancers and personalized therapies.

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Comparison with Competing Therapies

Parameter	Platinol (Cisplatin)	Carboplatin	Oxaliplatin	Emerging Agents
Efficacy	High in many cancers	Slightly lower in some	Comparable	Varies (targeted, immuno)
Toxicity	Nephrotoxicity, neurotoxicity	Hematologic, fewer renal issues	Peripheral neuropathy	Variable
Cost	Low	Moderate	Moderate	High (novel agents)
Formulation Options	Standard, nanoparticle (experimental)	Standard	Standard	Experimental

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FAQs

1. What are the primary clinical indications for Platinol (cisplatin)?

Cisplatin's primary indications include non-small cell lung cancer (NSCLC), ovarian cancer, bladder cancer, testicular cancer, and head & neck cancers. Its efficacy is well-established in these settings, often as part of combination chemotherapy regimens.

2. How does current clinical trial activity impact Platinol’s future use?

Active trials exploring combination therapies (e.g., with immuno-oncology agents) and novel formulations suggest potential for expanded indications and improved safety profiles, which may enhance Platinol’s therapeutic relevance.

3. What are the major market challenges facing Platinol?

Challenges include toxicity management (nephro- and neurotoxicity), competition from targeted therapies and immunotherapies, regulatory hurdles for new formulations, and rising costs in some regions.

4. How do emerging formulations influence the market for cisplatin?

Nanoparticle and liposomal formulations (currently under investigation) aim to reduce systemic toxicity and improve pharmacokinetics, potentially expanding the eligible patient population and increasing market share.

5. What are the key factors driving the global growth projection for Platinol?

The key factors are the ongoing clinical development of new combination regimens, formulation innovations, global adoption especially in emerging markets, and the drug’s cost-effectiveness which sustains its role in low-resource settings.

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Key Takeaways

• Clinical Evolution: Ongoing trials aim to refine cisplatin's role via combination therapies and innovative formulations, potentially broadening its indications.
• Market Resilience: Despite rising competition, cisplatin remains a leading agent due to efficacy, affordability, and global availability.
• Growth Opportunities: Formulation improvements, personalized therapy strategies, and expansion into new therapeutic areas are pivotal.
• Competitive Dynamics: The key competitors include carboplatin and oxaliplatin; cisplatin maintains its central position owing to proven efficacy and cost advantage.
• Regulatory Outlook: Anticipated approvals of advanced formulations and combinations will likely sustain market relevance through 2030.

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References

[1] IQVIA (2022). Global Oncology Market Report.
[2] GlobalData (2022). Oncology Drug Market Analytics.
[3] FDA (2022). Label Expansion for Platinum Agents.
[4] ClinicalTrials.gov (2023). Summary of ongoing cisplatin trials.
[5] Market Research Future (2023). Oncology Market Forecasts.

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Note: All projections are estimates based on current clinical and market data, subject to change with future developments.