LUNAR-4 trial halted as NovoCure (NASDAQ: NVCR) pivots to real-world data

Rhea-AI Filing Summary

NovoCure Limited reported that its subsidiary Novocure GmbH has decided to terminate the LUNAR-4 clinical trial. LUNAR-4 is a phase 2, single-arm, open-label, multinational study evaluating Tumor Treating Fields used together with pembrolizumab for patients with metastatic non-small cell lung cancer who were previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.

The company explains that the availability of real-world evidence will allow it to achieve the trial’s objectives without continuing this interventional clinical study. NovoCure states that this decision is not related to any safety concerns.

Insights

Biopharma pipeline and clinical strategy analyst

NovoCure halts a phase 2 NSCLC trial, citing sufficient real-world data and no safety concerns.

NovoCure is ending the LUNAR-4 phase 2 trial in metastatic non-small cell lung cancer, which tested Tumor Treating Fields with pembrolizumab in patients previously treated with PD-1/PD-L1 therapy and platinum-based chemotherapy. The company indicates that real-world evidence can now meet the study’s objectives, so continuing an interventional trial is no longer required.

The filing explicitly notes that the decision is not related to safety concerns, which reduces the risk that the termination signals a product safety issue. Instead, the shift toward using existing real-world data suggests a change in evidence-generation strategy rather than a change in the underlying technology or indication priorities.

Future disclosures in company filings may clarify how the real-world evidence will be used in regulatory or commercial discussions and whether alternative studies will replace LUNAR-4 in this patient population.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

What did NovoCure (NVCR) announce in this 8-K?

NovoCure reported that its subsidiary Novocure GmbH has decided to terminate the LUNAR-4 clinical trial, a phase 2 study in metastatic non-small cell lung cancer using Tumor Treating Fields with pembrolizumab.

Why is NovoCure terminating the LUNAR-4 trial?

NovoCure states that the availability of real-world evidence will enable it to achieve the objectives of the LUNAR-4 trial without the need for an interventional clinical study.

Is the LUNAR-4 trial termination related to safety concerns for NovoCure therapies?

The company states that the decision to terminate LUNAR-4 is not related to any safety concerns.

What was the design of NovoCure’s LUNAR-4 study?

LUNAR-4 was a phase 2, single-arm, open-label, multinational study of Tumor Treating Fields given with pembrolizumab for metastatic non-small cell lung cancer previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.

Which NovoCure entity was responsible for the LUNAR-4 trial?

Novocure GmbH, a subsidiary of NovoCure Limited, acted as the sponsor of the LUNAR-4 trial.

Does this 8-K include financial statements or new financial data for NovoCure?

The 8-K lists only an exhibit for the cover page interactive data file and does not present additional financial statements or earnings data.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Understanding 8-K Material Events →

Accepted by SEC EDGAR 08/28/2025 - 07:03 AM Learn about SEC filing dates

0001645113false00016451132025-08-222025-08-31

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

August 28, 2025

Date of Report (date of earliest event reported)

NovoCure Limited

(Exact name of registrant as specified in its charter)

Jersey			001-37565						98-1057807
(State or other jurisdiction of incorporation or organization)			(Commission File Number)						(I.R.S. Employer Identification No.)
No. 4 The Forum, Grenville Street			St. Helier			Jersey			JE2 4UF
(Address of Principal Executive Offices)									(Zip Code)

+44 (0) 15 3475 6700

Registrant's telephone number, including area code

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class			Trading Symbol(s)			Name of each exchange on which registered
Ordinary Shares, no par value			NVCR			The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

o

Item 7.01 Regulation FD Disclosure

On August 28, 2025, Novocure GmbH, a subsidiary of NovoCure Limited (the "Company" or "Novocure"), as sponsor, notified trial sites that it has decided to terminate its LUNAR-4 trial. LUNAR-4 is a phase 2, single arm, open-label, multinational study of Tumor Treating Fields concomitant with pembrolizumab for the treatment of metastatic non-small cell lung cancer (NSCLC) previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy. The availability of real-world evidence will enable Novocure to achieve the objectives of LUNAR-4 without the need for an interventional clinical study. This decision is not related to any safety concerns.

The information contained in this Item 7.01 of this Current Report shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

(d)    Exhibits

Exhibit No.			Description
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

NovoCure Limited

(Registrant)

Date: August 28, 2025

By: /s/ Christoph Brackmann

Name: Christoph Brackmann

Title: Chief Financial Officer